Systems and methods for on-demand stabilization of an endoscope
The robotic system dynamically adjusts the endoscope's bending stiffness using pull wires to stabilize the tip and maintain precise positioning, addressing deflection issues during procedures, thereby improving procedural efficiency and accuracy.
Patent Information
- Application Number
- PCT/US2025/041657
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-08-15
- Filing Date
- 2025-08-12
- Publication Date
- 2026-02-19
AI Technical Summary
Endoscopes experience undesirable deflection during procedures due to external forces applied through working channels, necessitating manual or robotic adjustments that are inefficient and prone to error, especially in robotic systems where the endoscope tip position is not maintained without continuous user intervention.
A robotic system dynamically adjusts the bending stiffness of the endoscope's bending section through pull wires, increasing stiffness to stabilize the tip and reduce deflection, and decreasing stiffness for flexibility during navigation, using real-time sensor data and control algorithms to maintain precise positioning.
Enhances procedural efficiency and accuracy by providing on-demand stabilization of the endoscope tip, allowing seamless maneuverability and stable tool deployment without manual intervention, reducing the risk of unintended movement and tissue damage.
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Figure US2025041657_19022026_PF_FP_ABST
Abstract
Description
Atorney Docket No. 55441-730601SYSTEMS AND METHODS FOR ON-DEMAND STABILIZATION OF AN ENDOSCOPECROSS-REFERENCE
[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 683,471, filed on August 15, 2024, which is entirely incorporated herein by reference.BACKGROUND
[0002] During endoscopy procedures, an endoscope is used to examine the interior of hollow organs or cavities in the body, with the endoscope being inserted directly into the organ. Sometimes, working channel tools such as biopsy forceps or treatment instruments are inserted through a channel within the endoscope. However, the stiffness of these tools and / or the force to push in the tool through the working channel can cause the endoscope to deflect, particularly during sensitive procedures such as biopsies where maintaining a constant position of the endoscope tip is crucial. Traditionally, physicians have had to make real-time manual adjustments using the endoscope handle lever to maintain the position of the tip, a task that is mentally taxing, requires constant adjustment, and can lead to procedural inefficiencies and potential for error. This issue remains even with advancements in robotic endoscopy where users control the position of the endoscope tip using a controller. For instance, with robotic endoscopes, a user may use a controller to achieve a certain position of the endoscope tip. Ideally, without force exerted on the endoscope, the tip position is maintained until a command to change the position. However, during operation, the endoscope tip may have undesirable deflection such as when a tool is passing through a working channel of the endoscope as the endoscope’s bending section needs to be sufficiently flexible to allow it passing through tortuous passageways. In particular, when the endoscope is inside of an airway of a subject having a tortuous configuration, inserting a tool through the working channel can exert extra force to the bending section causing undesirable movement of the tip position due to the insufficient stiffness of the bending section.SUMMARY
[0003] Recognized herein is a need for a robotic endoscope that can be stabilized on- demand. In particular, it is desirable to robotically control a change of stiffness in a bending section of the robotic endoscope. The present disclosure addresses the above needs by providing methods and systems that can robotically increase a stiffness of the bending section thereby stabilizing the bending section and tip of the endoscope and robotically decrease the stiffness ofAtomey Docket No. 55441-730601 the bending section thereby allowing for sufficient compliance / flexibility in the bending section such as during navigation. Unlike conventional methods relying on physical structures to vary a bending stiffness which lacks the flexibility to change the bending stiffness on-demand while the endoscope is placed inside of a subject, the on-demand stabilization feature of the present disclosure beneficially allows for robotic control of changing the bending stiffness of a bending section of the endoscope without requiring modifying a physical structure of the endoscope.
[0004] The present disclosure provides systems, devices, methods, and techniques to improve the performance and accuracy of an articulating flexible endoscope. These systems, devices, methods, and techniques disclosed herein may allow for robotically changing a stiffness of the endoscope while the endoscope is navigated to a target site inside a subject. In some embodiments, the stiffness of a bending section of the endoscope may be increased upon a robotic command thereby stabilizing a tip portion of the endoscope. In some embodiments, the bending stiffness of the bending section may be increased by computing a compression pull-force or a compression pull-length for each of a plurality of pull wires and executing a robotic command to pull the plurality of pull wires to reach the compression pull-force or the compression pull-length respectively, thereby increasing the flexural rigidity of the bending section.
[0005] The compression pull-force may also be referred to as tension which are utilized interchangeably throughout the specification unless context suggested otherwise. The term “compression pull-length” may also be referred to as “pull-length” which are utilized interchangeably throughout the specification unless context suggested otherwise. The compression pull-force or compression pull-length may be a calibrated target tension or calibrated target pull-length. In some cases, the target tension or the target pull-length may be determined based at least in part on a desired increase in the flexural rigidity of the bending section and calibrated to compensate for an undesired deflection of the endoscope tip caused by compressing the bending section to increase the flexural rigidity. In some cases, the desired increase in the flexural rigidity of the bending section may be predicted based on an expected force to deflect the tip portion of the endoscope. For instance, greater amount of increase in the flexural rigidity is required when greater amount of force is expected. In some instances, the expected force may be predicted based at least in part on a current tortuosity of the endoscope (e.g., greater force corresponds to greater tortuosity for inserting a tool through a working channel), rigidity of the tool to be inserted through the working channel, and / or other factors can be used to infer an external force to be exerted on the endoscope. In some cases, the expected force may be predicted based on a predetermined relationship between the force and the one orAtomey Docket No. 55441-730601 more factors (e.g., tortuosity, stiffness of tool, material, etc.). In some cases, the relationship may be created based on theoretical modeling, empirical data or utilizing a calibration process.
[0006] In some cases, the compression pull-force or compression pull-length may be computed based at least in part on a current bend angle of the endoscope's distal tip and a desired increase in the flexural rigidity of the bending section. In some cases, when all the pull wires are pulled to increase the rigidity of the endoscope by compressing the bending section, undesired deflection of the tip may be caused. To correct for the undesired deflection as result of the increase in compression force in the flexible elongate body of the endoscope, the present disclosure provides a pull -length-based method and a tension-based method for determining the compression pull-force or the compression pull-length for each of the plurality of pull wires thereby increasing the bending stiffness without causing a deflection of the endoscope tip.
[0007] In some embodiments of the present disclosure, upon entering into the mode to stabilize the tip of endoscope (i.e., stabilization mode) or upon determining a desired increase in the bending stiffness of the bending section is required, the methods herein may execute a pulllength-based algorithm or a tension-based algorithm to determine a pull-length or a tension for each of the plurality of pull wires. In some cases, the pull-length or a tension for each of the plurality of pull wires may be based on one or more calibration parameters associated with a bend angle.
[0008] In some cases, a control algorithm may be implemented to increase the tension or pull the plurality of pull wires based on the above computation result and generate commands to an instrument driving mechanism, along with an articulation function that can be strategically disabled and re-enabled for optimal control during various procedural stages. The systems, devices, methods, and techniques disclosed herein, using critical sensor data inputs for calibration, significantly improve the endoscope's performance while ensuring cost efficiency.
[0009] The methods for on-demand stabilization of the endoscope bending section and / or endoscope tip during operation (e.g., the insertion of working channel tools) can be applied to any type of flexible endoscopes.
[0010] In an aspect, a method for stabilizing an articulatable flexible endoscope is provided. The method comprises: (a) navigating the articulatable flexible endoscope towards a target site, where the articulatable flexible endoscope comprises a bending section steerable by a plurality of pull wires; (b) computing a tension or a compression pull-force for the plurality of pull wires based at least in part on i) a target increase in a flexural rigidity of the bending section and ii) a current bend angle of a distal tip portion of the articulatable flexible endoscope; and (c)Atomey Docket No. 55441-730601 executing a control algorithm to apply a force to the plurality of pull wires until reaching the compression pull-force or the compression pull-length, thereby stabilizing the distal tip portion or the bending section of the articulatable flexible endoscope.
[0011] In a related yet separate aspect, a system for stabilizing an articulatable flexible endoscope is provided. The system comprises one or more processors configured to execute instructions to perform operations comprising: (a) navigating the articulatable flexible endoscope towards a target site, where the articulatable flexible endoscope comprises a bending section steerable by a plurality of pull wires; (b) computing a tension or a compression pull-force for the plurality of pull wires based at least in part on i) a target increase in a flexural rigidity of the bending section and ii) a current bend angle of a distal tip portion of the articulatable flexible endoscope; and (c) executing a control algorithm to apply a force to the plurality of pull wires until reaching the compression pull-force or the compression pull-length, thereby stabilizing the distal tip portion or the bending section of the articulatable flexible endoscope.
[0012] In some embodiments, the target increase in the flexural rigidity of the bending section is predetermined. In some embodiments, the predetermined target increase in the flexural rigidity of the bending section is based at least in part on an undesired deflection of the distal tip portion caused by inserting an instrument into a working channel of the articulatable flexible endoscope. In some embodiments, the target tension, or the target pull-length for the plurality of pull wires is further computed based on calibration information. In some cases, the calibration information may comprise a set of compensation tensions or compensation lengths for the plurality of pull wires at various bend angles. In some embodiments, the control algorithm comprises generating a command to an instrument driving mechanism (IDM) actuating the plurality of pull wires. In some cases, the command is to pull the plurality of pull wires simultaneously using a ramp trajectory. In some embodiments, the method further comprises disabling an articulation function of the articulatable flexible endoscope prior to executing the control algorithm in (c). In some embodiments, the method further comprises re-enabling the articulation function of the articulatable flexible endoscope after executing the control algorithm in (c). In some cases, the re-enabling the articulation function comprises releasing the target tension or the target pull-length for the plurality of pull wires.
[0013] In another aspect, a system for stabilizing an articulatable flexible endoscope is provided. In some embodiments, the system comprises a navigation unit configured to guide the articulatable flexible endoscope towards a target site, where the articulatable flexible endoscope comprises a bending section steerable by a plurality of pull wires. In some embodiments, the system further comprises a processing unit configured to compute a compression-pull force or aAtomey Docket No. 55441-730601 compression pull-length for the plurality of pull wires based at least in part on i) a target increase in a flexural rigidity of the bending section and ii) a current bend angle of a distal tip portion of the articulatable flexible endoscope.
[0014] In some embodiments, the system further comprises a control unit configured to execute a control algorithm to apply a force to the plurality of pull wires until reaching the compression pull-force (i.e., tension) or the compression pull-length, thereby stabilizing the distal tip portion or the bending section of the articulatable flexible endoscope. In some embodiments, the processing unit is configured to compute the target increase in the flexural rigidity of the bending section as predetermined. In some embodiments, the processing unit is configured to compute the target increase in the flexural rigidity of the bending section as predetermined based at least in part on an undesired deflection of the distal tip portion caused by inserting an instrument into a working channel of the articulatable flexible endoscope. In some embodiments, the processing unit is further configured to compute the target tension or the target pull-length for the plurality of pull wires based on calibration information. In some embodiments, the calibration information comprises a set of compensation tensions or compensation lengths for the plurality of pull wires at various bend angles. In some embodiments, the control unit is configured to generate a command to an instrument driving mechanism (IDM) actuating the plurality of pull wires. In some embodiments, the command is to pull the plurality of pull wires simultaneously using a ramp trajectory. In some embodiments, the system is further configured to disable an articulation function of the articulatable flexible endoscope prior to executing the control algorithm. In some embodiments, the system is further configured to re-enable the articulation function of the articulatable flexible endoscope after executing the control algorithm. In some embodiments, re-enabling the articulation function comprises releasing the target tension or the target pull-length for the plurality of pull wires.
[0015] It's important to note that the endoscope components and various devices mentioned in this disclosure can be utilized in a broad range of minimally invasive surgical, therapeutic, or diagnostic procedures. These may involve a variety of tissues, including but not limited to heart, bladder, and lung tissue, along with other anatomical regions of a patient's body. The systems, devices, methods, and techniques mentioned herein can be applied in the digestive system, which might include the esophagus, liver, stomach, and colon, as well as the urinary tract. In addition, these can be implemented in the respiratory system, involving the bronchus, lungs, and other related areas. Therefore, the robotic endoscope that offers enhanced stabilization as mentioned in this disclosure is versatile and has broad applicability across various medical procedures.Atomey Docket No. 55441-730601BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings (also “Figure” and “FIG.” herein), of which:
[0017] FIG. 1 illustrates an embodiment of an endoscope system insertion shaft, in accordance with some embodiments of the present disclosure.
[0018] FIG. 2 illustrates a two-dimensional geometric representation of an endoscope bending section, in accordance with some embodiments of the present disclosure.
[0019] FIG. 3 illustrates a two-dimensional representation of an endoscope bending section, in accordance with some embodiments of the present disclosure.
[0020] FIG. 4 illustrates an example of a method for stabilizing an endoscope, in accordance with some embodiments of the present disclosure.
[0021] FIG. 5 illustrates an example of a flexible endoscope, in accordance with some embodiments of the present disclosure.
[0022] FIG. 6 shows an example of a robotic bronchoscope comprising a handle portion and a flexible elongate member.
[0023] FIG. 7 shows an example of an instrument driving mechanism providing mechanical interface to the handle portion of the robotic bronchoscope.
[0024] FIG. 8 shows an example of a distal tip of an endoscope.
[0025] FIG. 9 shows an exemplary distal portion of the catheter with integrated imaging device and the illumination device.
[0026] FIG. 10 show an example of a distal portion with integrated imaging device and the illumination device.
[0027] FIG. 11 shows another example of a distal portion with integrated imaging device and the illumination device.
[0028] FIG. 12 shows an example of integrating distal ends of pull wires to the steerable portion of an endoscope.Atorney Docket No. 55441-730601DETAILED DESCRIPTION
[0029] While various embodiments of the invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions may occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed.
[0030] The embodiments disclosed herein may be combined in one or more of many ways to provide a robotic endoscopic system with improved performance. The methods and systems herein may or may not be used on live subject. The embodiments disclosed herein may be combined in one or more of many ways to provide improved diagnosis and therapy to a patient. The disclosed embodiments may be combined with existing methods and apparatus to provide improved treatment, such as combination with known methods of pulmonary diagnosis, surgery and surgery of other tissues and organs, for example. It is to be understood that any one or more of the algorithms and steps as described herein may be combined with any one or more additional methods and steps of the methods and apparatus as described herein, the drawings and supporting text provide descriptions in accordance with embodiments.
[0031] Endoscopy procedures employ an endoscope to explore the internal facets of a hollow organ or cavity of the body. Unlike numerous other medical imaging methodologies, endoscopes are inserted directly into the organ. A flexible endoscope, capable of delivering intuitive steering and control, proves to be useful in diagnosing and treating diseases accessible through any natural orifice in the body. Depending on the clinical requirement, the endoscope might be designated as a bronchoscope, ureteroscope, colonoscope, gastroscope, ENT scope, among others. For instance, a flexible bronchoscope could be employed for lung cancer diagnosis or surgical treatment.
[0032] Similarly, flexible endoscopy is used to inspect and treat disorders of the gastrointestinal (GI) tract, without the need for an external incision on the patient's body. The endoscope is introduced into the upper or lower GI tracts respectively, via the mouth or anus. A miniature camera at the distal end captures images of the GI wall assisting clinicians in their diagnosis of GI diseases. Straightforward surgical procedures such as polypectomy and biopsy may be performed by introducing a flexible tool via a working channel to reach the site of interest at the distal end.
[0033] In endoscopic procedures, maintaining the precise position of the endoscope tip is critical, particularly when the endoscope is positioned at a target site within the body. However,Atomey Docket No. 55441-730601 this task presents ongoing challenges. For example, the insertion of tools through the endoscope's working channel can introduce external forces — due to tool stiffness or insertion resistance — that may cause the bending section of the endoscope to deflect. Such deflection can result in loss of the target view or, in more severe cases, unintended contact with or damage to surrounding tissue.
[0034] Traditionally, physicians have had to manually compensate for these disturbances in real time, actively adjusting the endoscope tip’s position as tools are inserted. This manual effort is cognitively demanding and requires continual attention, often leading to procedural inefficiencies and increasing the likelihood of human error. Even with the emergence of robotic endoscopy systems — where users manipulate the endoscope tip using a control interface — this issue remains. External forces applied to the endoscope can still result in unintended tip displacement, requiring user intervention to correct.
[0035] Accordingly, there exists a growing need for a system that can provide on-demand stabilization of the endoscope's bending section, particularly during tool insertion or in response to other external disturbances that may affect endoscope positioning.
[0036] While exemplary embodiments will be primarily directed at a device or system for bronchoscopy or colonoscope, one of skill in the art will appreciate that this is not intended to be limiting, and the devices described herein may be used for other therapeutic or diagnostic procedures and in various anatomical regions of a patient’s body. The provided device or system may be utilized in urology, gynecology, rhinology, otology, laryngoscopy, gastroenterology with the endoscopes, combined devices including endoscope and instruments, endoscopes with localization functions, one of skill in the art will appreciate that this is not intended to be limiting, and the devices described herein may be used for other therapeutic or diagnostic procedures and in other anatomical regions of a patient’s body, such as such as brain, heart, lungs, intestines, eyes, skin, kidney, liver, pancreas, stomach, uterus, ovaries, testicles, bladder, ear, nose, mouth, soft tissues such as bone marrow, adipose tissue, muscle, glandular and mucosal tissue, spinal and nerve tissue, cartilage, hard biological tissues such as teeth, bone and the like, as well as body lumens and passages such as the sinuses, ureter, colon, esophagus, lung passages, blood vessels and throat, and various others, in the forms of: NeuroendoScope, EncephaloScope, Ophthalmoscope, OtoScope, RhinoScope, LaryngoScope, GastroScope, EsophagoScope, BronchoScope, ThoracoScope, PleuroScope, AngioScope, MediastinoScope, NephroScope, GastroScope, DuodenoScope, CholeodoScope, CholangioScope, LaparoScope, AmioScope, UreteroScope, HysteroScope, CystoScope, ProctoScope, ColonoScope, ArthroScope,Atomey Docket No. 55441-730601SialendoScope, Orthopedic Endoscopes, and others, in combination with various tools or instruments.
[0037] The endoscope systems and apparatuses herein may be combined in one or more of many ways to provide improved diagnosis and therapy to a patient. Systems and apparatuses provided herein may be combined with existing methods and apparatus to provide improved treatment, such as combination with known methods of pulmonary diagnosis, surgery and surgery of other tissues and organs, for example. It is to be understood that any one or more of the structures and steps as described herein may be combined with any one or more additional structures and steps of the methods and apparatus as described herein, the drawings and supporting text provide descriptions in accordance with embodiments.
[0038] In one aspect of the present disclosure, systems and methods are provided for dynamically adjusting the bending stiffness (also referred to as flexural rigidity) of an endoscope’s bending section through robotic control. This enables real-time stabilization of the bending section and distal tip of the endoscope during operation, such as when external forces are applied (e.g., tool insertion through the working channel), and provides sufficient flexibility for maneuvering when needed.
[0039] Unlike conventional endoscopes that rely on passive mechanical structures (e.g., variable durometers, embedded support rods, or pre-tensioned segments) to set or modulate bending stiffness, the present disclosure introduces an on-demand, actively controlled stiffness modulation system. This robotic actuation does not require physical modification or reconfiguration of the endoscope’s structure once inside a subject, thereby enabling stiffness control to be performed at any time and at any position within the body.
[0040] The term “flexural rigidity”, may also be referred to as bending stiffness, which is a mechanical property that quantifies a structure’s resistance to bending when subjected to an external force. In some cases, a flexural rigidity of the endoscope’s bending section refers to the ability of that section to resist angular or curvilinear deformation along its axis under applied loads. The flexural rigidity may be represented as the product of the material's modulus of elasticity (E) and the area moment of inertia (I) of the cross-sectional geometry (i.e., El). In flexible robotic instruments such as endoscopes, the effective flexural rigidity is not only determined by passive material properties and geometry, but also dynamically influenced by active mechanical constraints, such as tension or compression applied to internal actuation elements (e.g., pull wires or tendons). In embodiments of the present disclosure, increasing the compression force on the bending section — through coordinated actuation of the pull wires —Atomey Docket No. 55441-730601 raises internal friction between components within the bending section, resulting in a real-time increase in effective flexural rigidity. This enhanced rigidity stabilizes the bending section and distal tip of the endoscope, reducing unwanted movement in response to external forces (e.g., from tool insertion). Conversely, releasing the compressive force decreases internal friction and restores flexibility, allowing for controlled navigation.
[0041] The disclosed system may comprise one or more actuation units that are configured to adjust tension or compression in pull wires, tendon sheaths, or similar tension elements embedded in or adjacent to the bending section. By increasing the mechanical force (e.g., tension, compression, or displacement) applied to these elements, the system increases the resistance of the bending section to deflection, thereby transitioning the system into a high- stiffness or "stabilization" state. Conversely, by reducing the applied mechanical force, the system permits greater compliance, enabling smooth articulation during navigation through anatomical pathways.
[0042] In some embodiments, the system may provide at least two distinct operational modes: a stabilization mode and a regular mode. These modes can be selected and engaged robotically and dynamically, allowing for seamless transition during an ongoing procedure. The system can perform this mode switching based on user input, predefined procedural steps, sensor feedback (e.g., force sensors, position encoders), or positional data indicating the endoscope’s location within the body. In some cases, in the stabilization mode, the bending stiffness of the endoscope's bending section is increased. This may be achieved by increasing the tension, compression, or effective pull length applied to one or more pull wires, thereby reducing the flexibility of the section and allowing it to resist deflection caused by external forces — such as those resulting from the insertion of stiff tools through the working channel or manipulation of accessories at the distal end. In regular mode, the bending section returns to a compliant state or in a range of bending stiffness that is suitable for navigation. This may be done by releasing or reducing the mechanical force applied to the pull wires, restoring their default slack or tension configuration, thereby recovering the full range of articulation and flexibility. The bending stiffness can be further modified or adjusted at a granular level within each of the regular mode and the stabilization mode. This ability to switch between modes and / or adjusting the bending stiffness without withdrawing or modifying the endoscope provides a significant advantage in maintaining procedural efficiency and precision. It allows the endoscope to be both highly maneuverable during navigation and stably fixed during therapeutic or diagnostic tool deployment.Atomey Docket No. 55441-730601
[0043] Whenever the term “at least,” “greater than,” or “greater than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “at least,” “greater than” or “greater than or equal to” applies to each of the numerical values in that series of numerical values. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.
[0044] Whenever the term “no more than,” “less than,” or “less than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “no more than,” “less than,” or “less than or equal to” applies to each of the numerical values in that series of numerical values. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.
[0045] As used herein, the terms distal and proximal may generally refer to locations referenced from the apparatus, and may be opposite of anatomical references. For example, a distal location of a primary shaft or catheter may correspond to a proximal location of an elongate member of the patient, and a proximal location of the primary sheath or catheter may correspond to a distal location of the elongate member of the patient.On-demand stabilization methods and algorithms
[0046] The present disclosure provides robotic systems and methods configured to dynamically modify the mechanical stiffness of an endoscope while the endoscope is actively navigated or during operation within a subject’s body. In particular, the disclosed systems may allow for real-time modulation of the bending stiffness (i.e., flexural rigidity) of a bending section of the endoscope — such as the distal articulation section — thereby offering precise control over the stability of the endoscope tip during critical procedural events (e.g., tool insertion, tissue targeting, or biopsy).
[0047] In an aspect, the bending stiffness may be increased in response to a robotic control signal, thereby stabilizing the distal tip and resisting undesired deflection due to external mechanical disturbances. This increase in stiffness may be achieved by controlling a plurality of pull wires (also referred to as actuation tendons or tendons), which are routed along the longitudinal axis of the flexible endoscope body and terminate near the distal bending section. These pull wires may be capable of articulating the bending section in various directions (e.g., pitch, yaw, or compound trajectories) when actuated individually or in coordinated fashion.
[0048] The stiffness modulation may be implemented by computing a target compression force (tension) or compression displacement (pull-length) for each pull wire and actuating the wires to reach the computed target. Applying such compressive force effectively increasesAtomey Docket No. 55441-730601 internal friction and contact pressure between adjacent mechanical elements (e.g., rings, coils, or links) within the bending section, resulting in a measurable increase in flexural rigidity.
[0049] The compression pull-force or compression pull-length may be a calibrated target tension or calibrated target pull-length. In some embodiments, the target pull-length or target compression force may be calibrated based on preoperative or intraoperative parameters. Calibration compensates for unintended geometric effects such as undesired tip deflection or non-uniform deformation, which may arise due to asymmetric compression of the bending section. The calibrated values may be dynamically adjusted during a procedure based on realtime sensing or predicted mechanical behavior of the endoscope.
[0050] In some cases, the target tension or the target pull-length may be determined based at least in part on a desired increase in the flexural rigidity of the bending section and calibrated to compensate for an undesired deflection of the endoscope tip caused by compressing the bending section for increasing the flexural rigidity. The tension or pull-length may be computed based on a current bend angle or an articulation (orientation and degree) of the endoscope's distal tip and a desired increase in the flexural rigidity of the bending section.
[0051] In certain implementations, the system may further predict the magnitude of external forces expected to act on the endoscope. For example, when a rigid surgical tool is inserted through a working channel, it may apply longitudinal or lateral forces that risk displacing the endoscope. To mitigate this, the system may estimate a desired flexural rigidity threshold sufficient to resist these forces without significant tip displacement. In some cases, the expected force may be estimated based on the tortuosity (curvature or path complexity) of the endoscope’s insertion path, the known rigidity or geometry of the tool being inserted, preoperative imaging data, or empirical models established via bench or clinical testing that relate force magnitude to anatomical conditions (e.g., colon geometry, airway constraints).
[0052] In some cases, the desired increase in the flexural rigidity of the bending section may be determined based on an expected force to deflect the tip portion of the endoscope. For instance, greater amount of increase in the flexural rigidity is required when greater amount of force is expected. In some instances, the expected force may be predicted based at least in part on a current tortuosity of the endoscope (e.g., greater force corresponds to greater tortuosity for inserting a tool through a working channel), rigidity of the tool to be inserted through the working channel, and / or other factors can be used to infer an external force to be exerted on the endoscope. In some cases, the expected force may be predicted based on a predetermined relationship between the force and the tortuosity. The relationship may be created based onAtomey Docket No. 55441-730601 empirical data for example. As an example, the system may implement a force-tortuosity model, optionally trained on historical usage data, to determine a required increase in bending stiffness prior to or during tool insertion.
[0053] A recognized challenge in applying compressive forces to increase bending stiffness is that symmetrical actuation of all pull wires can lead to unintended distal tip deflection, especially if the pull wires are not evenly tensioned or the bending section has asymmetric mechanical properties. To address this, the disclosure provides algorithmic compensation techniques to ensure that increased stiffness does not adversely alter the intended orientation or position of the endoscope tip. To correct for the undesired deflection as result of the increase in compression force in the flexible elongate body of the endoscope, the present disclosure provides a pull -length-based method and a tension-based method for determining the compression pull-force or the compression pull-length for each of the plurality of pull wires thereby increasing the bending stiffness without causing a deflection of the endoscope tip. These control methods may be deployed in real time to actively maintain distal tip position while compressively stiffening the bending section.
[0054] In some embodiments, upon entering into the mode to stabilize the tip of endoscope (i.e., stabilization mode) or upon determining a desired increase in the bending stiffness of the bending section is required, the methods herein may execute a pull-length-based algorithm or a tension-based algorithm to compute a pull-length or a tension for each of the plurality of pull wires. In some cases, the pull-length or a tension for each of the plurality of pull wires may be computed based on one or more calibration parameters associated with a bend angle. When a transition is required into a stabilization mode, either in a feed-forward manner or in response to real-time events (e.g., tool insertion through a working channel), the system executes a control algorithm that determines a specific tension or pull-length command for each of the plurality of pull wires. As an example, these values may be derived using calibration parameters including, a current angular configuration of the bending section, compliance profiles of the wire paths, and / or prior measurements associated with similar maneuvers.
[0055] In some cases, a control algorithm may be implemented to increase the tension or pull the plurality of pull wires based on the above computation result and generate commands to an instrument driving mechanism, along with an articulation function that can be strategically disabled and re-enabled for optimal control during various procedural stages. In some cases, the actuation of the pull wires is executed via a robotic instrument drive mechanism (e.g., motor- driven spools, capstans, or actuators), which receives commands from the stabilization control module. To avoid interference with intentional endoscope articulation, an articulation overrideAtomey Docket No. 55441-730601 function may be provided, allowing the system to temporarily disable free-tip movement during stiffening and re-enable it once stabilization is complete
[0056] The described stabilization methods can be applicable to robotically actuated flexible endoscopes, including colonoscopes, bronchoscopes, ureteroscopes, and other catheterbased surgical instruments. These techniques enhance procedural accuracy and safety, particularly in high-precision tasks that require stable positioning under variable mechanical loading conditions.
[0057] In an aspect disclosed herein are methods for stabilizing an articulatable flexible endoscope. In some embodiments, the method comprises (a) navigating the articulatable flexible endoscope towards a target site. In some cases, the articulatable flexible endoscope comprises a bending section steerable by a plurality of pull wires (also referred to as “tendons”); (b) computing a tension or a compression pull-force for the plurality of pull wires based at least in part on i) a target increase in a flexural rigidity of the bending section and ii) a current bend angle of a distal tip portion of the articulatable flexible endoscope; and (c) executing a control algorithm to apply a force to the plurality of pull wires until reaching the compression pull-force or the compression pull-length, thereby stabilizing the distal tip portion or the bending section of the articulatable flexible endoscope.
[0058] In some instances, the method further comprises computing the tension or the pull-length for each of the plurality of pull wires based at least in part on a current bend angle of a distal tip portion of the articulatable flexible endoscope. In some cases, the current bend angle may be based on robotic command (e.g., command for articulating the endoscope). Alternatively, the current bend angle is measured utilizing one or more sensors such as one or more of: optical sensor measurements, goniometer measurements, image analysis techniques, hall effect sensor measurements, inertial measurement unit (IMU) readings, capacitive bend sensor measurements, and flex sensor readings.
[0059] In some cases, the method comprises determining a target increase in the flexural rigidity of the one or more endoscope components (e.g., such as the bending section). In some instances, the target increase in the flexural rigidity of the one or more endoscope components is predetermined. For example, the target increase amount in flexural rigidity may be manually defined or adjustable by a user. In some cases, the target increase amount in flexural rigidity may be determined dynamically based on predetermine rules. For example, one or more rules may define a target increase amount associated with an operation to be conducted in the stabilization mode (e.g., inserting a tool through a working channel, type of tool, etc.). For instance, a userAtomey Docket No. 55441-730601 may be prompted to select from options within a user interface the purpose or reason for stabilization (e.g., inserting a tool or other operation), the system and method herein may automatically determine a desired target increase amount in the flexural rigidity.
[0060] In some instances, the target increase in the flexural rigidity of the bending section may be determined to be sufficient to bear an expected force. The expected force may cause an undesired movement or deflection of the distal tip portion without the increase in bending stiffness of the bending section. For example, the undesired deflection of the distal tip portion is caused by inserting an instrument into a working channel of the articulatable flexible endoscope. In some instances, the target increase may be determined based at least in part on the stiffness of the working channel tool, the material properties of the bending section, the extent of the bending section's initial articulation, the predicted path of the endoscope, the dynamic forces encountered within the patient's body such as peristaltic motion or heartbeat-induced movements, and the required precision for the medical procedure being performed.
[0061] In some cases, a target increase in the flexural rigidity of the bending section may be determined based on an expected force to deflect the tip portion of the endoscope. For instance, greater amount of increase in the flexural rigidity is required when greater amount of force is expected. In some instances, the expected force may be predicted based at least in part on a current tortuosity of the endoscope. For example, greater tortuosity can result in greater force for pushing a tool through a working channel. The expected force may be predicted based on any other factors such as rigidity of the tool to be inserted through the working channel, and factors that can be used to infer an external force to be exerted on the endoscope. In some cases, the expected force may be predicted based on a predetermined relationship between the force and the one or more factors (e.g., tortuosity, stiffness of tool, material, etc.). In some cases, the relationship may be created based on theoretical modeling, empirical data or utilizing a calibration process.
[0062] In some cases, the method herein may allow for robotically controlling a stiffness of at least bending section of an endoscope. In some instances, the method may maintain, increase, or decrease the stiffness of the bending section of an endoscope utilizing a control algorithm. The control algorithm may be executed to pull the plurality of pull wires according to a predetermined function (e.g., ramp speed, order of pulling the plurality of pull wires, etc.). In some embodiments, the control algorithm may generate robotic command to actuate a plurality of motors to pull the pull wires simultaneously until the compression-pull length or tension for each individual pull wire is met respectively. For example, a simultaneous pull may comprise a uniform application of tension across all tendons. The simultaneous pulling on the pull wiresAtomey Docket No. 55441-730601 beneficially allows for the position of the bending section is maintained until the desired compression force is reached.
[0063] In some cases, the method may increase the stiffness of the one or more endoscope components by a desired amount (e.g., sufficient to bear an expected force to be exerted on the endoscope) thereby stabilizing the distal portion of the endoscope. The increased stiffness of the endoscope bending section may allow the distal tip portion of the endoscope to maintain a current position and / orientation under a force exerted on the endoscope. In some cases, the stiffness of the endoscope bending section may be increased from any current articulation configuration and the increase in the bending stiffness may allow the endoscope to retain the position of the endoscope tip in the presence of an external force (e.g., force caused by inserting a tool through a working channel of the endoscope). In some cases, the amount of stiffness increase may be dynamically adjusted based on an expected force thereby preserving the position of the endoscope tip in a desired articulated position.
[0064] The capability of robotically changing of a bending stiffness of the endoscope may beneficially allow for a convenient switch between a ‘stabilization mode’ and a ‘regular mode.’ For instance, when stabilization is not required, the method may comprise robotically decreasing the stiffness of bending section to eliminate the tension applied to the plurality of pull wires in the stabilization mode.
[0065] FIG. 1 illustrates a plurality of pull wires 103 for articulating a distal portion of an endoscope 100. The plurality of pull wires 103 may run through a flexible elongate body of the endoscope or catheter. As depicted in FIG. 1, the plurality of pull wires may be pulled to articulate a distal portion of the endoscope. A distal end of the plurality of pull wires may be attached to a bending section. The distal portion of the catheter may be steered by the plurality of pull wires. The distal portion of the catheter may be made of any suitable material such as copolymers, polymers, metals, or alloys such that it may be bent in a desired bend angle and bend direction by the pull wires. In some embodiments, the proximal end or terminal end of one or more pull wires may be coupled to a driving mechanism (e.g., gears, pulleys, capstan etc.) details of which are described later herein. In some cases, at least two, three, four, or more pull wires may be utilized for articulating the flexible endoscope or catheter.
[0066] In some embodiments, the endoscope system may comprise a plurality of pull wires to control the articulation (e.g., articulation orientation and articulation angle) of the endoscope's bending section. The plurality of pull wires may steer or articulate (e.g., up, down, pitch, yaw, or any direction in-between) a bending section or distal portion of the catheter. TheAtomey Docket No. 55441-730601 plurality of pull wires may comprise a configuration that may or may not directly correspond to the articulation directions. As illustrated in the example, the plurality of directional pull wires 103 may comprise Tu (Up), Tr (Right), Td (Down), and T1 (Left). In some instances, Tu (Up), Tr (Right), Td (Down), and T1 (Left) may each be associated with a specific direction of movement. In some instances, the method may comprise controlling each of the directional pull wires individually. For example, controlling each of the directional pull wires individually may cause the endoscope tip to bend in the corresponding direction. In an example, if the Tr (Right) wire is pulled, it may cause the one or more endoscope components (e.g., endoscope tip) to bend to the right. In further examples, the pulling the Td (Down) wire may facilitate a downward movement of the one or more endoscope components (e.g., endoscope tip).
[0067] Alternatively, the pull wires can have any other configuration that may not directly correspond to the articulation direction. For instance, a three-pull-wire configuration may have three pull wires separated by about 120° and a virtual mapping algorithm may map the three-wire configuration to a four-wire configuration for controlling the articulation of the tip utilizing the three pull wires.
[0068] The plurality of pull wires may be individually controlled. In some embodiments, each pull wire may be connected to the distal portion directly. As shown in the example 1220 of FIG. 12, the plurality of pull wires 1223 may be attached to an integrally formed structure 1221 of the distal tip portion. For example, the integrally formed structure 1221 may be grooves that are molded with the distal tip. The grooves may have a dimension or size matching the dimension of the distal end 1221 of the pull wire such that the pull wire can be conveniently crimped at the distal end. This may advantageously improve the assembly efficiency. In some instances, the pull wires may be rigidly affixed to the grooves at the distal end such that the distal end of the pull wire may not be permitted to move relative to the distal portion of the catheter.
[0069] During navigation, the plurality of pull wires may be pulled or tensioned to steer the distal portion of the endoscope. In some cases, it is desirable to maintain a current position and orientation of the distal portion of the endoscope while the endoscope is placed inside of a subject. For instances, upon reaching the desired location within the body, a user may insert an instrument such as a medical tool through a working channel within the endoscope to perform various operations at the target site. The medical tool operated by a user or a controller may comprise a variety of instruments such as a biopsy forceps, needle, brush, catheter, guidewire, snare, stent, balloon, dilator, or an electrosurgical cutting or coagulation device. Pushing an instrument through the endoscope working channel may cause unintended displacement / deflection of the endoscope thus loosing the current position / orientation of theAtomey Docket No. 55441-730601 distal tip. Conventional methods to solve the issue may involve repositioning the tip of the endoscope such as by moving the tip back to the target orientation or position based on positional sensor data. However, such conventional methods require user operations and there may be safety risk as the endoscope may have been deflected already and injured the tissue.
[0070] The present disclosure beneficially stabilizes the endoscope tip portion on-demand by providing methods and algorithms to robotically modify a mechanical property of the endoscope (e.g., flexural rigidity / bending stiffness of the bending section). This beneficially allows for preserving an orientation and position of the endoscope tip even under undesired external force. This beneficially prevents the endoscope tip from unintended movement. In some embodiments, the mechanical property of the flexible body of the endoscope is changed by controlling the plurality of pull wires to increase or decrease a compression force resulting in an increase in the internal friction in the bending section which affects the flexural rigidity.
[0071] The present disclosure may provide a stabilization algorithm to dynamically control the plurality of pull wires thereby increasing a bending stiffness on-demand. The stabilization algorithm may comprise determining an amount of tension applied to each pull wire based on force (i.e., tension-based control) or a pull-length for each pull wire (i.e., position-based control). As described elsewhere herein, a tension or pull-length for a pull wire may be controlled by the rotation of a capstan located within a handle portion of the endoscope.
[0072] The stabilization algorithm may stabilize the bending section by pulling the actuation tendons (pull wires) to compress the bending section thereby modifying the mechanical property, i.e., bending stiffness or flexural rigidity of the bending section. The compression can result in an increase in the internal friction in the bending section which increases the flexural rigidity.
[0073] In some cases, the method comprises computing a target tension or a target pulllength (T) for the plurality of pull wires based on a desired increase in flexural rigidity of the bending section. In some instances, the target tension or the target pull-length for the plurality of pull wires is determined such that the flexural rigidity is sufficient to bear an external force without substantially deflecting the distal tip. The target tension or pull-length may be calibrated based on calibration information to account for a potential deflection of the distal tip caused by compressing the bending section.
[0074] As described above, in some cases, the desired increase in the flexural rigidity of the bending section may be predicted based on an expected force to deflect the tip portion of the endoscope. For instance, greater amount of increase in the flexural rigidity is required whenAtomey Docket No. 55441-730601 greater amount of force is expected. In some instances, the expected force may be predicted based at least in part on a current tortuosity of the endoscope (e.g., greater force corresponds to greater tortuosity for inserting a tool through a working channel), rigidity of the tool to be inserted through the working channel, and / or other factors can be used to infer an external force to be exerted on the endoscope. In some cases, the expected force may be predicted based on a predetermined relationship between the force and the tortuosity. The relationship may be created based on empirical data for example.
[0075] In some cases, the method may comprise pulling the bending section taut to compress the bending section thereby increasing the flexural rigidity. Details about a control algorithm for executing the pulling command are described later herein. In some cases, the method may comprise determining the increased amount of flexural rigidity thereby preventing an undesired movement or deflection of the endoscope tip (e.g., during working channel tool insertion). It should be noted that the endoscope tip may be stabilized for various purposes in addition to working channel tool insertion (e.g., working channel tool removal, or other scenarios when force is exerted on the endoscope causing undesired movement).
[0076] In some cases, the method may comprise stabilizing the endoscope tip thereby maintaining the endoscope tip portion or bending section substantially undeflected during insertion of one or more tools in the working channel. The term “substantially undeflected” may generally refer to the endoscope tip portion is stabilized within a range of the current position or a current orientation. For example, the endoscope tip portion may not move beyond 1mm, 2mm, 3mm, 4mm and the like from a current position in the stabilization mode. In some cases, a lateral, vertical, or angular distance between the deflected position of endoscope tip with respect to the initial position of the endoscope tip may comprise at most about 0mm, about 1mm, about 2mm, about 3mm, about 4mm, about 5mm, about 6mm, about 7mm, about 8mm, about 9mm, about 10mm, about 11mm, about 12mm or any number greater than 12 mm or any number in between.
[0077] In some cases, when all the pull wires are pulled by the same amount (e.g., target pull-length or target tension) to increase the rigidity of the endoscope by compressing the bending section, an undesired deflection of the endoscope tip may be caused. To correct for the undesired deflection as a result of the compression force exerted on the flexible elongate body of the endoscope, the present disclosure provides a pull-length-based calibration method and a tension-based calibration method for determining the pull-length or the tension for each of the plurality of pull wires thereby increasing the bending stiffness without causing deflection of the tip. The tension or pull-length for each pull wire may be computed based at least in part onAtomey Docket No. 55441-730601 calibration information. For example, the calibration information may comprise a set of compensation tensions or compensation lengths for the plurality of pull wires at various bend angles. The set of compensation tensions or compensation lengths are utilized to compensate for an undesired deflection of the endoscope tip caused by increasing intension in the pull wires.Position-Based Stabilization algorithm
[0078] In some embodiments, a position-based stabilization algorithm is provided for robotically enhancing the stability of an endoscope's bending section. The algorithm may calculate a target pull-length for each individual actuation tendon (or pull wire) such that an appropriate compression is applied to the bending section, thereby increasing its flexural rigidity (bending stiffness) without introducing undesired changes in the distal tip orientation.
[0079] In some embodiments, the stabilization algorithm may be position-based. The stabilization algorithm may comprise parameters that are used for determining a pull length for each pull wire (tendon) such that a desired compression is applied to the endoscope bending section to achieve stabilization. When a uniform pull-length is applied simultaneously to all tendons, the bending section may become stiffer, but this uniform compression can also lead to a deflection of the endoscope tip — altering its intended orientation or heading. To counteract this, a position-based calibration model is introduced. This model accounts for mechanical properties of the endoscope, such as tendon elasticity, section geometry, and friction-induced resistance, and may be expressed in either two-dimensional or three-dimensional representations. In one example, a 2D geometric model is used to demonstrate how pulling all tendons by the same length results in tip displacement, as illustrated in FIG. 2. More complex implementations may employ finite element models or empirical calibration data to map tendon displacement to bending section deformation.
[0080] The pull length may be calibrated based on one or more calibration parameters such that the compression force for increasing bending stiffness may not cause undesired deflection of the tip of endoscope. In some embodiments, a position-based calibration method is provided. In some cases, the position-based calibration method may comprise determining one or more calibration parameters for position-based stabilization.
[0081] In some cases, the position-based calibration algorithm may comprise modeling the bending section of the endoscope utilizing a constant-curvature geometry to determine the undesired deflection. The bending section is stabilized by compressing the bending section. In some embodiments, the plurality of actuation tendons are pulled to compress the bending section thereby modifying the bending stiffness properties. The compression can result in an increase inAtomey Docket No. 55441-730601 the internal friction in the bending section which affects the flexural rigidity (bending stiffness). Pulling all the pull wires by the same amount or uniform length can increase the flexural rigidity but may also result in a change in the bend angle. FIG. 2 illustrates a visual depiction of the effect of pulling all tendons by a uniform length 201 and the undesired deflection as a result of the uniform pulling length.
[0082] As illustrated in FIG. 2, a two-dimensional geometric representation 200 of a bending section is provided. In FIG. 2, the proximal end of the bending section is shown at the coordinate (0,0). The center line of the bending section is represented by line 204. In some cases, the center line 204 may also represent the direction or 'throw' of an instrument (e.g., biopsy tool passing through the working channel of the endoscope) or the heading of the endoscope tip. Alternatively, the working channel may not be coaxial with the center line whereas the direction of the working channel is aligned with the center line. Upon pulling the plurality of pull wires by a uniform length (e.g., same amount of target pull-length), the compressed state 201 of the bending section when all tendons are uniformly pulled is deflected from the original position or orientation 202. The difference between the regular state of the bending section 202 and a uniform pull across all tendons state 201 is the undesired deflection. To maintain the bend angle at the distal tip (e.g., endoscope tip) while enhancing the endoscope's stability, one or more calibration parameters are obtained such that a pull length for each pull wire is computed individually.
[0083] Although FIG. 2 illustrates a 2D model, it should be understood that the model for the bending section can be a 3D model. The model may be predetermined based on various properties of the bending section such as the elasticity of tendons, friction, and elasticity of the bending section and / or shaft and the like. In some cases, the model may be predetermined or updated based on empirical or calibration data. In some cases, finite element analysis may be utilized to create the model to determine the deflection caused by a specific compression force.Calibration for Position-based stabilization
[0084] To mitigate the above effect, the system determines a set of individual pull-length values for each tendon. Rather than applying a single uniform length T, the control system computes a plurality of calibrated lengths [T+C1,T+C2,...,T+Cn], where each Ci is a compensation length tailored to a specific tendon. The goal is to achieve the target increase in bending stiffness while preserving the original articulation angle and spatial orientation of the endoscope tip. These compensation values may be derived in Model-Based Calibration such as using a pre-defined or dynamically generated motion control model, where the algorithmAtomey Docket No. 55441-730601 simulates how uniform compression affects bend angle and computes required adjustments for each tendon. Alternatively, these compensation values may be derived using empirical calibration where the system may empirically determine the compensation lengths by executing controlled pull-length variations during a calibration phase, while observing the tip's movement and iteratively minimizing deflection.
[0085] The relationship between tendon pull-length and bend angle deflection may be precomputed across a matrix of articulation configurations and compression targets. This relationship can be stored in a lookup table or used to train a predictive model that generalizes across device variants.
[0086] In some cases, the model may be utilized to determine a pull-length for each individual pull wire during a calibration process. The pull-length for each individual pull wire may be computed based on i) a target pull-length (T) required for compressing the bending section thereby achieving a desired bending stiffness and ii) a calibration parameter (e.g., compensation length) to compensate for the bend angle caused by the compression. For example, the model may be utilized to calculate the undesired deflection (e.g., degree and direction of a bend angle) caused by a uniform target pull-length (T) applied to all the pull wires. The undesired bend angle may be calculated for various uniform target pull-length applied when the endoscope is at various articulation angles.
[0087] Alternatively, the model may not be required for determining the compensation length. For instance, the compensation length may be determined based at least in part on a relationship between the target / uniform pull-length T and a bending section with a specific articulation configuration (bend angle). The relationship may be determined during a calibration process. For example, the calibration process may be performed to determine the compensation length to be applied to each pull wire by applying variable pull-length to each pull wire without causing the deflection. The calibration process may comprise adjusting the pull-length for each pull wire while preserving the distal tip orientation and position. The calibration process may be repeated for various compression force (e.g., target pull-length) at various articulations (e.g., articulation angle and direction). The calibration process beneficially allows for achieving stabilization without adversely affecting the bending section heading i.e., compressing the bending section while maintaining the endoscope tip position.
[0088] In the position-based calibration method, the calibration parameter may be related to a pull length. For example, the calibration parameter may be related to a compensation lengthAtomey Docket No. 55441-730601 for a particular pull wire (e.g., Tu (Up), Tr (Right), Td (Down), and T1 (Left)) at a particular articulation angle at a selected target pull-length.
[0089] The calibration pull-length for each pull wire may be obtained during a calibration process. The calibration process may be performed offline. For instance, the calibration process may be performed on one or more endoscopic devices substantially the same as the endoscopic device being used for the medical procedure. For example, the one or more endoscopic devices utilized during the calibration process to obtain the one or more calibration parameters (i.e., a calibration pull-length) may have the same pull wire configurations, substantially the same mechanical property of the bending section and / or the endoscope (e.g., same dimension such as length, thickness of bending section or shaft, material, etc.). Alternatively, the calibration may be performed onsite and for each individual endoscope device.
[0090] In some instances, the position-based calibration method may start with determining a target pull-length to be applied uniformly to all the tendons. The target pull-length (T) may be determined as described above to achieve a desired increase in flexural rigidity in the bending section. Uniformly pulling all the tendons may lead to a change in the bend angle. In some instances, the method may compute the bend angle utilizing the model and method as described above. For example, the change in bend angle caused by the uniform pull-length applied to the tendons may be a function of the model of the bending section, a current articulation orientation and degree, the target pull-length / desired compression force.Alternatively, the method may not compute the bend angle or may not create the model.
[0091] Next, the position-based calibration algorithm may compute a plurality of calibration parameters to compensate for the change in the bend angle. In some cases, the position-based calibration algorithm may comprise calibrating a target pull-length for each pull wire. For example, instead of pulling tendons by the uniform pull-length T, the plurality of tendons may be pulled by a length of T+Cl, T+C2... T+Cn, where Cn represents a compensation length and the number indicates a compensation value corresponding to a tendon. The compensation length for each individual tendon may be obtained in the calibration process.
[0092] In some instances, the compensation length for each individual tendon may be computed utilizing a motion control model. The motion control model may be used to compensate for potential deviations in the bend angle. The motion control model may be used to compute the values [Cl, C2, . . ., Cn], In some cases, the values may be computed based at least in part on the change of bend angle. For example, if a uniform pull-length T results in a change in bend angle or bend angle deviation of 10 degrees, the motion control model may be utilized toAtomey Docket No. 55441-730601 compute the values [Cl, C2, Cn] such that when a pull length of T+Cl, T+C2... T+Cn is applied to the respective tendon, the resultant bend angle deviation reduced or close to zero.Alternatively, the values may be computed based at least in part on a relationship between the target / uniform pull-length T and a bending section with a specific articulation configuration (bend angle). The relationship may be the motion control model that is determined during a calibration process as described above.
[0093] In some instances, the position-based calibration parameters may comprise one or more of the compensation lengths of the pull wires, the rate of change of the pull wire length, or the amount of articulation of the endoscope tip. In some instances, the position-based calibration parameters may comprise a delay or response time. For example, the parameters may be dynamically adjusted based on the current state of the endoscope. In some cases, the calibration parameters may comprise a speed for pulling the pull wire and / or the order of pulling the pull wires without causing a deflection.
[0094] Real-time tendon position data may be acquired using integrated position sensors located in the endoscope handle or actuation module. The sensors may include rotary encoders, potentiometers, optical encoders, magnetic / Hall effect sensors, capacitive or inductive sensors, or gyroscopic feedback units. These measurements allow the robotic control unit to execute closed- loop control of tendon displacement with high accuracy and temporal resolution.
[0095] In some cases, the pull-length for each pull wire may be measured by a position sensing mechanism. For example, the position sensing mechanism may include an encoder located at the handle portion of the endoscope. In some instances, the position sensing mechanism may comprise a rotary encoder. The position sensing mechanism may comprise any suitable sensor that can be utilized to measure or derive a pull-length of the pull wire, such as, a potentiometer, a capacitive sensor, an inductive sensor, an optical encoder, a magnetic sensor, a Hall effect sensor, or a gyroscope. The real-time pull-length for each pull wire may be utilized by the robotic control unit of the system for driving / actuating the plurality of pull wires by certain pull length.
[0096] In some implementations, calibration parameters are obtained during an offline process using one or more surrogate endoscopic units that are mechanically and dimensionally similar to the clinical device. In other cases, calibration is performed onsite and tailored to the individual endoscope, thereby compensating for device-specific variations in material properties, tendon pre-tension, or manufacturing tolerances.Atomey Docket No. 55441-730601Tension-Based Stabilization algorithm
[0097] In some embodiments, a tension-based stabilization algorithm is provided for dynamically modifying the mechanical properties of the endoscope’s bending section to achieve tip stabilization. Unlike position-based methods, which rely on displacement of pull wires, the tension-based method calculates and applies targeted tensile forces to the actuation tendons (pull wires). The algorithm determines appropriate tension magnitudes to achieve a desired level of compression in the bending section. This compression beneficially increases internal friction within the structure (e.g., between segments or layers), thereby enhancing flexural rigidity (also known as bending stiffness) and resisting unintended deflection under external forces. The algorithm may be configured to ensure such tension-based stabilization occurs without inducing unwanted tip articulation or directional bias.
[0098] In some embodiments, the stabilization algorithm may be tension-based. The stabilization algorithm may comprise calibration parameters that are used for determining a tension to be applied to each pull wire (tendon) such that a desired compression is applied to the endoscope bending section to achieve stabilization without causing undesired deflection of the tip of endoscope. In some embodiments, a tension-based calibration method is provided. The tension-based calibration method may comprise determining calibration parameters for tensionbased stabilization.
[0099] In some cases, the tension-based calibration algorithm may comprise modeling the bending section of the endoscope utilizing a beam theory with a linear elasticity. Similar to the position-based method, the bending section is stabilized by compressing the bending section. In some embodiments, the plurality of actuation tendons are pulled to compress the bending section thereby modifying the bending stiffness properties. The compression can result in an increase in the internal friction in the bending section which affects the flexural rigidity (bending stiffness).
[0100] In some instances, the tension-based calibration method may comprise modeling the bending section to estimate an undesired deflection caused by pulling all the pull wires by the same amount of target tension. For example, the modeling the bending section may comprise using one or more of beam theory, finite element methods, multibody dynamics, or other suitable engineering models. In further examples, the modeling the bending section may comprise coupling the one or more of beam theory finite element methods, multibody dynamics, or other suitable engineering models with a linear elasticity assumption.
[0101] In some cases, the tension-based calibration algorithm may comprise defining a relationship to correlate the bend angle and bending moment of the bending section. In someAtomey Docket No. 55441-730601 instances, the tension-based calibration algorithm may determine the relationship between the bend angle and bending moment of the bending section.
[0102] In some cases, the calibration algorithm may include defining a force-deflection response model of the bending section by deriving a mathematical relationship between bend angle (BA) (the angular displacement of the distal tip), bending moment (M) (the torque induced by tendon tension) and flexural rigidity (El) (a parameter representing resistance to bending). Such a relationship enables the controller to predict and compensate for small angular deflections when modifying tension, ensuring that the compressive load increases without altering the orientation of the distal tip. For example, the following formula for calculating the bend angle of the endoscope tip (BA) may be used: (Equation 1)
[0103] In Equation 1, 'L' may represent the length of the bending section, which is the part of the endoscope that may be articulated and bent. For example, the length may vary depending on the specific design of the endoscope and the requirements of the medical procedure. The flexural rigidity (El) is a key control parameter whereby increasing tendon tension increases compressive force in the bending section, which enhances internal segment-to- segment friction, and thereby increases El. However, if tendon tension is applied asymmetrically or without compensation, it may produce an unintended bending moment, leading to tip deflection.
[0104] The bending moment is a function of the tensions. In some cases, the bending moment is a function of the tensions applied by the actuation tendons and the location at which they are mounted within the endoscope (e.g., pull wires configuration).
[0105] In an ideal scenario where the design is symmetric, a uniform increase in tension in an agonistic (pulling) wire and an antagonistic (releasing) wire may result in an increase in the compression force exerted on the bending section without changing or affecting the bend angle of the endoscope tip due to the bending moment remaining constant. In a well-calibrated system with symmetrical design, a balanced tension (i.e., equal and opposite forces applied to antagonistic tendon pairs) can increase compressive force in the bending section without changing the tip’s bend angle or heading. In some cases, the bending moment remains constant, and only the axial preload on the structure changes. This symmetric actuation is beneficial for achieving a neutral stabilization state, where the endoscope tip remains fixed in both position and orientation despite external disturbances.Atomey Docket No. 55441-730601
[0106] FIG. 3 shows an example of an endoscope bending section 300. In FIG. 3, 'm' denotes the bending moment, 'r' signifies the tendon-mounting-radius, and 't' represents tension, 't2' denotes the tension in the agonistic tendon (pulling), and 'tl ' denotes the tension in the antagonistic tendon (releasing). The bend angle 310 may be defined as the degree of bend with respect to the original or straight position of the endoscope's bending section. The bend angle may refer to the extent to which the endoscope's bending section has deviated from its initial straight orientation during the medical procedure. The bend angle may be aligned with the heading direction of the bending section. Following is an example of defining the bend angle:R * (t2— t- = — m (Equation 2)U > 0, t2> 0 (Equation 3)
[0107] As described above, in ideal scenario, when t2 and tl are identical i.e., uniform tension applied to the tendons, the bend angle is zero. However, in practice or in reality, a uniform increase in tl and t2 may impact the flexural rigidity thus bending properties of the bending section. Such change in the bending properties can result in undesired deflection of the endoscope tip. Such undesired deflection may be compensated utilizing a theoretical method or a calibration method.
[0108] The bend angle 310 may also serve as a feedback variable or control target. For example, during a stabilization phase, the system may attempt to maintain a constant bend angle while modulating internal tendon tensions (tl, t2) to increase internal compression and flexural rigidity. The system can adjust tl and t2 in a coordinated manner such that the resulting bending moment m remains unchanged, thereby preserving the tip’s pose while enhancing structural stiffness. As described above, under idealized conditions — such as when the agonistic and antagonistic tendon tensions (t2 and tl, respectively) are equal — there is no net bending moment, and therefore, the bend angle (BA) is theoretically zero. This scenario assumes perfect symmetry in tendon routing, uniform mechanical properties in the bending section, and negligible frictional or elastic effects. Under such conditions, a uniform increase in both tl and t2 merely increases the compression force applied to the bending section, thereby enhancing the flexural rigidity (i.e., the resistance to bending), without changing the pose or orientation of the endoscope tip.However, in practical scenarios, several non-ideal factors affect the system behavior. These include mechanical hysteresis, tendon elasticity, friction between components, structural asymmetry, and variations in material stiffness. As a result, a uniform increase in tl and t2 can inadvertently cause a shift in the bending moment, leading to undesired deflection of the endoscope tip. This undesired deflection undermines the positional stability of the endoscope,Atomey Docket No. 55441-730601 especially during precision procedures involving tool insertion or manipulation. To mitigate or correct this effect, the system may incorporate compensation strategies based on either (i) a theoretical model or (ii) a calibration-based approach.
[0109] In the case of theoretical method, Equation 2 may be extended to account for the nonlinear or nonuniform mechanical response of the bending section under applied tension. In some cases, instead of treating the bending moment (m) as a constant, it may be expressed as a function of tension, geometry, and material parameters, resulting in a modified form such as:R * (tl - t2) = (BA) * (E * I + f(tl, t2)) / ( L - ka(tl + t2)) (Equation 4)
[0110] In Equation 4, "R" symbolizes the tendon-mounting-radius (the radial distance from the centerline of the bending section to the location where each tendon (or pull wire) is anchored or routed) while "tl" and "t2" are representative of the tensions in the agonistic and antagonistic tendons, respectively. In Equation 4, "BA" refers to the bend angle of the bending section of the endoscope. In Equation 4, the product of "E" and "I" is indicative of the flexural rigidity of the bending section, where "E" is the Young's modulus and "I" is the moment of inertia. In Equation 4, the function f(tl ,t2) represents the changes in flexural rigidity that depend on the tensions in the tendons. "L" represents the length of the bending section, while ka(tl+t2) is a term used to account for the decrease in the length of the bending section due to the sum of the tensions in the two tendons, where "ka" is the axial stiffness.
[0111] Equation 4 models the interdependence between tendon tensions, resulting compression, flexural rigidity, axial contraction, and the resulting bend angle of the endoscope. In some embodiments, this model is used to calculate calibration parameters that enable tensionbased stabilization by determining tension profiles that result in desired compression without altering the orientation of the endoscope tip.
[0112] In some cases, the function f(tl, t2) may be determined empirically or offline through a calibration process. Once obtained, this function may be used to compute the optimal tension to be applied to each of the plurality of actuation tendons, such that the bending section is stabilized (compressed) without inducing a net bending moment or resulting in unintended deflection of the distal tip.
[0113] Alternatively, the tension applied to each of the plurality of tendons without causing bend angle change may be determined in a calibration process without the theoretical model. For example, the calibration process may determine a relationship between the tension adjustment parameters or the tension levels and a current articulation of the bending section (e.g., the direction of articulation, degree of articulation, etc.). The tension distribution across theAtomey Docket No. 55441-730601 actuation tendons that maintains a constant bend angle may be determined through an empirical calibration process rather than a theoretical model. In such cases, the calibration process may establish a lookup table, interpolation model, or parameterized mapping that relates tension adjustment factors to the current articulation configuration of the bending section. These articulation parameters may include, for example, the articulation direction, degree of articulation, or tip heading angle
[0114] In some cases, a relationship may also factor in the configuration of the pull wires (e.g., mounting location of the pull wires). For example, when the endoscope bending section is straight i.e., zero bend angle, all four pull wires may be pulled by the same amount in tension. The calibration may further incorporate structural configuration variables, such as the mounting positions of the pull wires, which may affect the mechanical response of the bending section. For example, when the bending section is in a neutral (straight) configuration — i.e., when the bend angle is zero — all four pull wires may be tensioned equally to a baseline value, thereby compressing the section without causing deflection.
[0115] In contrast, when the bending section is articulated, such as 90° to the left, the required tension distribution may deviate from uniform. For example, when the endoscope bending section is articulated 90° to the left (i.e., current bend angle 90° to the left), the tension levels may be set to X for the up and down wires, 1. IX for the left wire, and 0.9X for the right wire. The X parameter may represent the target tension and the coefficient factor such as 1.2, 1.1, 0.9, 0.8 and the like may be obtained from the calibration process. In some embodiments, the coefficient values may be parameterized as functions of articulation direction and magnitude, and may be precomputed and stored or dynamically interpolated during operation. In some cases, the coefficient factors may be a ratio among a plurality of tensions corresponding to the plurality of pull wires. For example, variable values for the coefficients may be applied to a pull wire at various different current articulation configuration and at various target tension X without causing a deflection of the distal tip.
[0116] In some cases, the control algorithm may calculate the tension applied to each pull wire based on a ratio of tension among the pull wires. The ratio at various current articulation configurations may be obtained from a calibration process as described above. For instance, a relationship among the ratio, articulation configurations (e.g., articulation direction and degree) and the pull wire configures (e.g., location of the pull wires) may be obtained from a calibration process where the ratio may be determined that may not cause substantial deflection of the distal tip. In some cases, the ratio may be based on the target tension or desired compression in the bending section. In some instances, the ratio is predetermined. In some instances, the ratio mayAtomey Docket No. 55441-730601 be calculated in real-time. For example, the ratio may be calculated before or during working tool insertion based on the relationship obtained from calibration, a current articulation and / or the target tension.
[0117] In some instances, the ratio may comprise a ratio of the tension of the up wire to the down wire, the down wire to the up wire, the left wire to the right wire, the right wire to the left wire, the up wire to the left wire, the left wire to the up wire, the up wire to the right wire, the right wire to the up wire, the down wire to the left wire, the left wire to the down wire, the down wire to the right wire, and the right wire to the down wire. For example, the known ratio may comprise about 0. IX, 0.2X, 0.3X, 0.4X, 0.5X, 0.6X, 0.7X, 0.8X, 0.9X, 1.0X, 1.1X, 1.2X, 1.3X, 1.4X, 1.5X, 1.6X, 1.7X, 1.8X, 1.9X, 2.0X, 2. IX, 2.2X, 2.3X, 2.4X, 2.5X, 2.6X, 2.7X, 2.8X,2.9X, 3. OX, 3. IX, 3.2X, 3.3X, 3.4X, 3.5X, 3.6X, 3.7X, 3.8X, 3.9X, 4.0X, 4.1X, 4.2X, 4.3X,4.4X, 4.5X, 4.6X, 4.7X, 4.8X, 4.9X, 5. OX, 5. IX, 5.2X, 5.3X, 5.4X, 5.5X, 5.6X, 5.7X, 5.8X,5.9X, 6.0X, 6. IX, 6.2X, 6.3X, 6.4X, 6.5X, 6.6X, 6.7X, 6.8X, 6.9X, 7.0X, 7. IX, 7.2X, 7.3X,7.4X, 7.5X, 7.6X, 7.7X, 7.8X, 7.9X, 8. OX, 8. IX, 8.2X, 8.3X, 8.4X, 8.5X, 8.6X, 8.7X, 8.8X,8.9X, 9.0X, 9. IX, 9.2X, 9.3X, 9.4X, 9.5X, 9.6X, 9.7X, 9.8X, 9.9X, lO.OX up to about lOOOx, or any number in between 0. IX and 1000X, or more than lOOOx.
[0118] In some instances, the control algorithm may be configured to control one or more endoscope components such that one or more of the following tension levels are applied to one or more pull wires: 0.1X, 0.2X, 0.3X, 0.4X, 0.5X, 0.6X, 0.7X, 0.8X, 0.9X, 1.0X, 1.1X, 1.2X, 1.3X, 1.4X, 1.5X, 1.6X, 1.7X, 1.8X, 1.9X, 2.0X, 2. IX, 2.2X, 2.3X, 2.4X, 2.5X, 2.6X, 2.7X, 2.8X,2.9X, 3. OX, 3. IX, 3.2X, 3.3X, 3.4X, 3.5X, 3.6X, 3.7X, 3.8X, 3.9X, 4.0X, 4.1X, 4.2X, 4.3X,4.4X, 4.5X, 4.6X, 4.7X, 4.8X, 4.9X, 5. OX, 5. IX, 5.2X, 5.3X, 5.4X, 5.5X, 5.6X, 5.7X, 5.8X,5.9X, 6.0X, 6. IX, 6.2X, 6.3X, 6.4X, 6.5X, 6.6X, 6.7X, 6.8X, 6.9X, 7.0X, 7. IX, 7.2X, 7.3X,7.4X, 7.5X, 7.6X, 7.7X, 7.8X, 7.9X, 8. OX, 8. IX, 8.2X, 8.3X, 8.4X, 8.5X, 8.6X, 8.7X, 8.8X,8.9X, 9.0X, 9. IX, 9.2X, 9.3X, 9.4X, 9.5X, 9.6X, 9.7X, 9.8X, 9.9X, lO.OX up to about lOOOx, or any number in between 0. IX and 1000X, or more than lOOOx.
[0119] In some cases, a control algorithm may be executed to apply a tension to each pull wire until reaching the compression pull-force as calculated above. In some instances, the control algorithm may receive the desired tension settings (e.g., compression pull-force) as an input and apply pull the plurality of pull wires at a speed according to a predetermined function and at a predetermined order (e.g., simultaneously). For example, the control algorithm may receive realtime feedback from a sensor that measures tension in the pull wire and generate a robotic command to actuate the motor for pulling the pull wire based on the sensor data.Atomey Docket No. 55441-730601
[0120] The tension applied to the pull wire may be measured by a tension sensing mechanism. In some instances, the tension sensing mechanism may comprise a torque sensor. For example, the tension sensing mechanism may comprise one or more of a load cell, a strain gauge, a piezoelectric sensor, a capacitive sensor, an optical fiber sensor, or a hall effect sensor.
[0121] In some embodiments, a current bend angle or articulation degree of the bending section or distal tip portion may be determined for determining the calibration parameters (e.g., ratio). The current bend angle or articulation degree may be obtained by the robotic command, sensor data (e.g., fluoroscopy), or position sensor data, a predetermined model for the path, 3D maps or models of the anatomical structures.
[0122] In some embodiments, the system may select the calibration method from the position-based method and the tension-based method based on a mechanical property of the endoscope (e.g., stiffness, elasticity, tensile strength, compressive strength, torsional rigidity, material properties (e.g., type of metal or plastic used), structural design (e.g., thickness, shape, and arrangement of the pull wires), frictional characteristics, etc.), and / or the available sensors deployed to the site. For example, position-based stabilization may be utilized when the bending section of the endoscope possesses a high degree of stiffness and low elasticity. In some instances, the tension-based stabilization method may be utilized when procedures comprise navigating through narrow or tortuous pathways or using additional tools which introduce extra forces and space constraints. In some instances, the tension-based stabilization method may be utilized when the bending section possesses a high frictional coefficient or specific material properties such as thermal properties or Poisson's ratio that need to be factored in.
[0123] The tension applied to the plurality of pull wires may or may not be identical. In some instances, the tension applied to the of pull wires may be different depending at least in part on a current articulation configuration or current bend angle of the bending section. The tensions applied to each of the pull wires may be a different percentage of a nominal amount. The different percentage may be based on the amount of articulation or bend angle the endoscope bending section is currently under.
[0124] In alternative embodiments, instead of or in addition to the calibration parameters, the system may utilize real-time sensor feedback to adjust the pull-length or tension applied to each of the pull wire thereby preserving the tip position. For example, a positional sensor (e.g., electromagnetic (EM) sensor) may be utilized to collect the real-time position data of the endoscope tip and a feedback control loop may be implemented so that the pull-wire tension is adjusted in order to maintain a constant EM position data.Atomey Docket No. 55441-730601Systems and Methods for Stabilization
[0125] FIG. 4. illustrates an example of a stabilization method for an endoscope (referred to as “stabilization method”) 400. In some cases, the stabilization method 400 is configured to stabilize the bending section and / or a distal tip portion of the endoscope 400. In some instances, the stabilization method 400 may be initiated through a user interface. For example, the user interface may permit a user to enable the stabilization mode 400 for the endoscope. For instance, upon reaching the intended destination, the user may activate a stabilize button (e.g., a physical button on the endoscope system or via a user interface displayed on the screen).
[0126] In some instances, the stabilization method 400 may be initiated not by the user interface. For example, the endoscope system may be programmed to automatically initiate the stabilization method in response to detected conditions. For example, the triggering conditions or events may comprise the detection of a desired deflection in the endoscope's bending section, the insertion of a working channel tool, or reaching a specific location within the patient's body.
[0127] In some instances, the stabilization method 400 may be initiated by at least one processor. For example, the endoscope system may comprise at least one processor that is configured to execute the stabilization method of the endoscope. In further examples, the processor may be configured to execute the stabilization method autonomously, (e.g.„ without requiring user intervention). In even further examples, the processor may be configured to accept user commands for executing at least part of the stabilization method.
[0128] In some cases, upon entering the stabilization mode, the articulation functionality of the endoscope may be disabled. The method may employ the position-based control of tendon or the tension-based control of tendon. The selection may be based on the property of the endoscope, available sensors on the system or other factors as described above.
[0129] In the position-based control of the endoscope's tendons, the compression-pull lengths for the plurality of pull wires are computed. The compression pull lengths may be computed utilizing the position-based stabilization algorithm as described above. For example, a target pull-length and a compensation length may be determined based on the current bend angle, and a-priori calibration parameters. The current bend angle may be obtained using the robotic command and / or sensor data as described above.
[0130] Upon determining the pull-length for each pull wire, the stabilization method further comprises executing a control algorithm to apply a tension each of the plurality of pull wires. The control algorithm may comprise generating a command to pull the pull wires simultaneously until the compression-pull length for each individual pull wire is metAtomey Docket No. 55441-730601 respectively. For example, a simultaneous pull may comprise a uniform application of tension across all tendons. The simultaneous pulling on the pull wires beneficially allows for the position of the bending section is maintained until the desired compression force is reached.
[0131] The control algorithm comprises generating a command to an instrument driving mechanism (IDM) pulling the plurality of pull wires simultaneously. In some cases, the command is to pull the plurality of pull wires simultaneously such as using a ramp trajectory (e.g., at a predetermined constant speed). The pull wires can be pulled utilizing any other suitable algorithm.
[0132] In some instances, the stabilization method further comprises overlaying the pull command on a nominal articulation command. For example, the overlaying operation may add the pull commands for tendon tension adjustments to the standard commands for the articulation of the endoscope. This allows for the endoscope maintaining the current endoscope's articulation while increasing the compression force in the bending section.
[0133] In some instances, the stabilization method further comprises transitioning the endoscope system into a waiting state. For example, the waiting state may serve as a pause phase where the endoscope system temporarily halts other operations while awaiting further commands. The waiting state may allow users to perform actions such as inserting a tool (e.g., such as a medical tool) through a working channel of the endoscope.
[0134] The user may exit the stabilization mode and return to the regular navigation mode to enable the articulation function. The user may switch to the regular articulation mode such as by pressing on the button or via the user interface as described above.
[0135] In some cases, existing the stabilizing mode may activate execution of a control algorithm to recover the state of the pull wires. The state of the pull wires may include the tension of the pull wires or the position of the pull wires prior to entering the stabilization mode. For example, the position of the pull wires may be recovered by executing a ramp trajectory to eliminate the compression-pull length for each pull wire.
[0136] In some instances, the rate at which these ramp trajectories are executed may be customized based on one or more medical treatment factors. For example, the one or more medical treatment factors may comprise one or more of the medical treatment mode, the characteristics of the endoscope and the treatment environment. In further examples, the alteration in pull wire tension may be implemented slowly for intricate procedures occurring within sensitive anatomical regions or may be administered at a faster pace if the endoscope operates within a sturdier environment.Atomey Docket No. 55441-730601
[0137] In some instances, the ramp trajectories may be linear, representing a constant rate of tension change over time. Other trajectories (e.g., exponential, trapezoidal, sinusoidal or wavelike trajectory, etc) may be employed to increase the compression force in the bending section.
[0138] In some cases, the stabilization method 400 further comprises re-enabling of the articulation functionality of the endoscope. For example, the re-enabling of the articulation functionality of the endoscope may conclude the stabilization method 400. In further examples, the re-enabling of the articulation functionality of the endoscope may bring the endoscope back to its normal operational state. In further examples, the re-enabling of the articulation functionality of the endoscope may bring the endoscope to a desired state of articulation.
[0139] In the cases when a tension-based algorithm is selected, the tension in the pull wires is adjusted to stabilize the endoscope's bending section. The compression pull forces may be computed utilizing the tension-based stabilization algorithm as described above. For example, target compression forces may be determined based on the current bend angle, and a-priori calibration parameters (e.g., ratio). The current bend angle may be obtained using the robotic command and / or sensor data as described above.
[0140] Upon determining the pull-force for each pull wire, the stabilization method further comprises executing a control algorithm to apply tension to the plurality of pull wires. The control algorithm may comprise pulling the pull wires simultaneously until the respective compression-pull force for each individual pull wire is met. For example, a simultaneous pull may comprise a uniform application of tension across all tendons. The simultaneous pulling on the pull wires beneficially allows for the position of the bending section is maintained until the desired compression force is reached.
[0141] The control algorithm comprises generating a command to an instrument driving mechanism (IDM) pulling the plurality of pull wires simultaneously. In some cases, the command is to pull the plurality of pull wires simultaneously such as using a ramp trajectory. The pull wires can be pulled utilizing any other suitable algorithm.
[0142] In some instances, the stabilization method further comprises overlaying the pull command on a nominal articulation command. For example, the overlaying operation may add the pull commands for tendon tension adjustments to the standard commands for the articulation of the endoscope. This allows for the endoscope maintaining the current endoscope's articulation while increasing the compression force in the bending section.
[0143] In some instances, the tension-based stabilization method further comprises transitioning the endoscope system into a waiting state. For example, the waiting state may serveAtomey Docket No. 55441-730601 as a pause phase where the endoscope system temporarily halts other operations while awaiting further commands. The waiting state may allow users to perform actions such as inserting a tool (e.g., such as a medical tool) through a working channel.
[0144] The user may exit the stabilization mode and return to the regular navigation mode or enable the articulation function. The user may switch to the regular articulation mode such as by pressing on the button or via the user interface as described above.
[0145] In some cases, existing the stabilizing mode may activate execution of a control algorithm to release recover the state of the pull wires. The state of the pull wires may include the tension of the pull wires or the position of the pull wires prior to entering the stabilization mode. For example, the position of the pull wires may be recovered by executing a ramp trajectory to eliminate the compression-pull force for each pull wire.
[0146] In some cases, the method may comprise generating a command to an instrument driving mechanism (IDM) actuating the plurality of pull wires. In some instances, the control algorithm is configured to generate a command to an instrument driving mechanism (IDM) actuating the plurality of pull wires. In some instances, the command is to pull the plurality of pull wires simultaneously using a ramp trajectory or other suitable trajectories (e.g., trapezoidal, sinusoidal or wave-like trajectory) that defines the speed or acceleration for pulling the pull wires.
[0147] In some cases, the method may comprise electromagnetic (EM) tracking of a position and orientation of the endoscope tip. In some instances, the method comprises embedding one or more EM sensors into the endoscope. For example, the method may comprise embedding one or more EM sensors into one or more of the endoscope tip, the endoscope handle, the endoscope bending section, the endoscope base, the endoscope insertion shaft, or any other component / portion of the endoscope. In further examples, the one or more EM sensors may be embedded along the length of the endoscope. In even further examples, the one or more electromagnetic (EM) sensors may comprise one or more fluxgate magnetometers, hall effect sensors, magneto-resistive sensors, magneto-inductive sensors, nuclear magnetic resonance (NMR) sensors, superconducting quantum interference device (SQUID) sensors, giant magnetoresistance (GMR) sensors, magnetoelastic sensors, reed switch sensors, or proton precession magnetometers.
[0148] In some instances, the one or more EM sensors interacts with an external EM field generator. For example, the EM sensor - EM filed generator interaction may provide precise data on the position and orientation of the one or more endoscope components (e.g., such as theAtomey Docket No. 55441-730601 endoscope tip). In further examples, the position and orientation of the one or more endoscope components (e.g., such as the endoscope tip) data is fed back into the control system (e.g., aiding in navigation). In even further examples, the feedback facilitates the dynamic adjustment of pull wire tension (e.g.., to maintain the endoscope's position).Flexible Endoscope System and Device
[0149] The stabilization method can be applied to any robotic endoscopes. In some embodiments, low-cost, single-use articulatable endoscope for diagnosis and treatment is provided and may be used in various applications such as bronchoscopy, urology, gynecology, arthroscopy, orthopedics, ENT, gastro-intestine endoscopy, neurosurgery, and various others. In some cases, the present disclosure provides a single-use, disposable, robotically controlled bronchoscope for use with a robotic system to enable diagnostic evaluation of lesions anywhere in the pulmonary anatomy. It should be noted that the provided endoscope systems may be used in various minimally invasive surgical procedures, therapeutic or diagnostic procedures that comprise various types of tissue including heart, bladder, and lung tissue, and in other anatomical regions of a patient’s body such as a digestive system, including but not limited to the esophagus, liver, stomach, colon, urinary tract, or a respiratory system, including but not limited to the bronchus, the lung, and various others.
[0150] Traditionally, endoscopes are designed to be reusable, necessitating thorough cleaning, disinfection, and sterilization after each procedure. These cleaning and disinfection procedures can be aggressive, aimed to eliminate all bacteria and germs. However, such procedures can also be harsh on the endoscopes themselves, leading to the need for complex designs to ensure that the endoscopes can withstand such harsh protocols. Periodic maintenance and repairs for these reusable endoscopes are often required.
[0151] In light of these challenges, low-cost, disposable medical devices designated for single-use have gained popularity, particularly for instruments that are challenging to clean adequately. These single-use, disposable devices, packaged in sterile wrappers, circumvent the risk of pathogenic cross-contamination of diseases such as HIV, Hepatitis, among others. Hospitals generally prefer the convenience of single-use disposable products as concerns of product age, overuse, breakage, malfunction, and sterilization are negated. However, traditional endoscopes comprise a handle that operators use to maneuver the endoscope. For single-use endoscopes, the handle generally encases the camera, expensive electronics, and mechanical structures at the proximal end to transmit video and enable users to maneuver the endoscope via a user interface. This leads to a high cost for the handle of a single-use endoscope.Atomey Docket No. 55441-730601
[0152] The endoscope herein may be an elongate device comprising a flexible elongate member. The articulatable flexible endoscope may comprise a bending section. The bending section may be articulated into one or more directions to control a direction of the endoscope. The articulatable flexible endoscope comprises an elongated member extending between a distal end and a proximal end and a distal tip portion connected to the distal end of the elongate member. The elongated member comprises a bending section steerable by one or more pull wires. In some embodiments, the proximal end is connected to a proximal portion comprising a driving mechanism for applying a force to the one or more pull wires. In some cases, the proximal portion is supported by a robotic arm.
[0153] In some embodiments, the stabilization methods and endoscope systems herein may be utilized for improving reliability and accuracy of controlling an operation of an endoscope. FIG. 5 illustrates an example of a flexible endoscope 500. As shown in FIG. 5, the flexible endoscope 500 may comprise a handle / proximal portion 509 and a flexible elongate member to be inserted inside of a subject. The flexible elongate member may comprise a shaft described above. In some embodiments, the flexible elongate member may comprise a proximal shaft (e.g., insertion shaft 501), steerable tip (e.g., tip 505), and a steerable section (active bending section 503). The shape sensing method and mechanism as described above may be applied to the insertion shaft, the bending section of a combination of both. The active bending section, and the proximal shaft section may be the same as those described elsewhere herein. The endoscope 500 may also be referred to as steerable catheter assembly as described elsewhere herein. In some cases, the endoscope 500 may be a single-use robotic endoscope. In some cases, the entire catheter assembly may be disposable. In some cases, at least a portion of the catheter assembly may be disposable. In some cases, the entire endoscope may be released from an instrument driving mechanism and may be disposed of. In some embodiment, the endoscope may contain varying levels of stiffness along the shaft, as to improve functional operation.
[0154] The endoscope or steerable catheter assembly 500 may comprise a handle portion 509 that may comprise one or more endoscope components configured to process image data, provide power, or establish communication with other external devices. For instance, the handle portion may comprise a circuitry and communication elements that enables electrical communication between the steerable catheter assembly 500 and an instrument driving mechanism (not shown), and any other external system or devices. In another example, the handle portion 509 may comprise circuitry elements such as power sources for powering the electronics (e.g., camera, electromagnetic sensor, and LED lights) of the endoscope.Atomey Docket No. 55441-730601
[0155] The one or more endoscope components located at the handle may be optimized such that expensive and complicated components may be allocated to the robotic support system, a hand-held controller or an instrument driving mechanism thereby reducing the cost and simplifying the design the disposable endoscope. The handle portion or proximal portion may provide an electrical and mechanical interface to allow for electrical communication and mechanical communication with the instrument driving mechanism. The instrument driving mechanism may comprise a set of motors that are actuated to rotationally drive a set of pull wires of the catheter. The handle portion of the catheter assembly may be mounted onto the instrument drive mechanism so that its pulley / capstans assemblies are driven by the set of motors. The number of pulleys may vary based on the pull wire configurations. In some cases, one, two, three, four, or more pull wires may be utilized for articulating the flexible endoscope or catheter.
[0156] The handle portion may be configured allowing the robotic bronchoscope to be disposable at reduced cost. For instance, classic manual and robotic bronchoscopes may have a cable in the proximal end of the bronchoscope handle. The cable often comprises illumination fibers, camera video cable, and other sensors fibers or cables such as electromagnetic (EM) sensors, or shape sensing fibers. Such complex cable may be expensive adding to the cost of the bronchoscope. The provided robotic bronchoscope may have an optimized design such that simplified structures and components may be employed while preserving the mechanical and electrical functionalities. In some cases, the handle portion of the robotic bronchoscope may employ a cable-free design while providing a mechanical / electrical interface to the catheter.
[0157] The electrical interface (e.g., printed circuit board) may allow image / video data and / or sensor data to be received by the communication module of the instrument driving mechanism and may be transmitted to other external devices / systems. In some cases, the electrical interface may establish electrical communication without cables or wires. For example, the interface may comprise pins soldered onto an electronics board such as a printed circuit board (PCB). For instance, receptacle connector (e.g., the female connector) is provided on the instrument driving mechanism as the mating interface. This may beneficially allow the endoscope to be quickly plugged into the instrument driving mechanism or robotic support without utilizing extra cables. Such type of electrical interface may also serve as a mechanical interface such that when the handle portion is plugged into the instrument driving mechanism, both mechanical and electrical coupling is established. Alternatively or in addition to, the instrument driving mechanism may provide a mechanical interface only. The handle portion may be in electrical communication with a modular wireless communication device or any other userAtomey Docket No. 55441-730601 device (e.g., portable / hand-held device or controller) for transmitting sensor data and / or receiving control signals.
[0158] In some cases, the handle portion 509 may comprise one or more mechanical control modules such as lure 511 for interfacing the irrigation system / aspiration system. In some cases, the handle portion may comprise lever / knob for articulation control. Alternatively, the articulation control may be located at a separate controller attached to the handle portion via the instrument driving mechanism.
[0159] The endoscope may be attached to a robotic support system or a hand-held controller via the instrument driving mechanism. The instrument driving mechanism may be provided by any suitable controller device (e.g., hand-held controller) that may or may not comprise a robotic system. The instrument driving mechanism may provide mechanical and electrical interface to the steerable catheter assembly 500. The mechanical interface may allow the steerable catheter assembly 500 to be releasably coupled to the instrument driving mechanism. For instance, the handle portion of the steerable catheter assembly may be attached to the instrument driving mechanism via quick install / release means, such as magnets, spring- loaded levels and the like. In some cases, the steerable catheter assembly may be coupled to or released from the instrument driving mechanism manually without using a tool (e.g., such as a medical tool).
[0160] In the illustrated example, the distal tip of the catheter or endoscope shaft is configured to be articulated / bent in two or more degrees of freedom to provide a desired camera view or control the direction of the endoscope. As illustrated in the example, imaging device (e.g., camera), position sensors (e.g., electromagnetic sensor) 507 is located at the endoscope tip of the catheter or endoscope shaft 505. For example, line of sight of the camera may be controlled by controlling the articulation of the active bending section 503. In some instances, the angle of the camera may be adjustable such that the line of sight may be adjusted without or in addition to articulating the distal tip of the catheter or endoscope shaft. For example, the camera may be oriented at an angle (e.g., tilt) with respect to the axial direction of the endoscope tip of the endoscope with aid of an optimal component.
[0161] The distal tip 505 may be a rigid component that allow for positioning sensors such as electromagnetic (EM) sensors, imaging devices (e.g., camera) and other electronic components (e.g., LED light source) being embedded at the distal tip.
[0162] In real-time EM tracking, the EM sensor comprising of one or more sensor coils embedded in one or more locations and orientations in the medical instrument (e.g., tip of theAtomey Docket No. 55441-730601 endoscopic tool) measures the variation in the EM field created by one or more static EM field generators positioned at a location close to a patient. The location information detected by the EM sensors is stored as EM data. The EM field generator (or transmitter), may be placed close to the patient to create a low intensity magnetic field that the embedded sensor may detect. The magnetic field induces small currents in the sensor coils of the EM sensor, which may be analyzed to determine the distance and angle between the EM sensor and the EM field generator. For example, the EM field generator may be positioned close to the patient torso during procedure to locate the EM sensor position in 3D space or may locate the EM sensor position and orientation in 5D or 6D space. This may provide a visual guide to an operator when driving the bronchoscope towards the target site.
[0163] The endoscope may have a unique design in the elongate member. In some cases, the active bending section 503, and the proximal shaft of the endoscope may consist of a single tube that incorporates a series of cuts (e.g., reliefs, slits, etc.) along its length to allow for improved flexibility, a desirable stiffness as well as the anti -prolapse feature (e.g., features to define a minimum bend radius).
[0164] As described above, the active bending section 503 may be configured to allow for bending in two or more degrees of freedom (e.g., articulation). A greater bending degree such as 180 and 270 degrees (or other articulation parameters for clinical indications) may be achieved by the unique structure of the active bending section. In some cases, a variable minimum bend radius along the axial axis of the elongate member may be provided such that an active bending section may comprise two or more different minimum bend radii.
[0165] The articulation of the endoscope may be controlled by applying force to the distal end of the endoscope via one or multiple pull wires. The one or more pull wires may be attached to the distal end of the endoscope. In the case of multiple pull wires, pulling one wire at a time may change the orientation of the distal tip to pitch up, down, left, right or any direction needed. In some cases, the pull wires may be anchored at the distal tip of the endoscope, running through the bending section, and entering the handle where they are coupled to a driving component (e.g., pulley). This handle pulley may interact with an output shaft from the robotic system.
[0166] In some embodiments, the proximal end or portion of one or more pull wires may be operatively coupled to various mechanisms (e.g., gears, pulleys, capstans, etc.) in the handle portion of the catheter assembly. The pull wire may be a metallic wire, cable, or thread, or it may be a polymeric wire, cable, or thread. The pull wire may also be made of natural or organic materials or fibers. The pull wire may be any type of suitable wire, cable, or thread capable ofAtomey Docket No. 55441-730601 supporting various kinds of loads without deformation, significant deformation, or breakage. The distal end / portion of one or more pull wires may be anchored or integrated to the distal portion of the catheter, such that operation of the pull wires by the control unit may apply force or tension to the distal portion which may steer or articulate (e.g., up, down, pitch, yaw, or any direction inbetween) at least the distal portion (e.g., flexible section) of the catheter.
[0167] The pull wires may be made of any suitable material such as stainless steel (e.g., SS316), metals, alloys, polymers, nylons, or biocompatible material. Pull wires may be a wire, cable, or a thread. In some embodiments, different pull wires may be made of different materials for varying the load bearing capabilities of the pull wires. In some embodiments, different sections of the pull wires may be made of different material to vary the stiffness and / or load bearing along the pull. In some embodiments, pull wires may be utilized for the transfer of electrical signals.
[0168] The proximal design may improve the reliability of the device without introducing extra cost allowing for a low-cost single-use endoscope. In another aspect of the invention, a single-use robotic endoscope is provided. The robotic endoscope may be a bronchoscope and may be the same as the steerable catheter assembly as described elsewhere herein. Traditional endoscopes may be complex in design and are usually configured to be re-used after procedures, which require thorough cleaning, dis-infection, or sterilization after each procedure. The existing endoscopes are often configured with complex structures to ensure the endoscopes may endure the cleaning, dis-infection, and sterilization processes. The provided robotic bronchoscope may be a single-use endoscope that may beneficially reduce cross-contamination between patients and infections. In some cases, the robotic bronchoscope may be delivered to the medical practitioner in a pre-sterilized package and are intended to be disposed of after a single-use.
[0169] As shown in FIG. 6, a robotic bronchoscope 620 may comprise a handle portion 613 and a flexible elongate member 1111. In some embodiments, the flexible elongate member 611 may comprise a shaft, steerable tip, and a steerable / active bending section. The robotic bronchoscope 620 may be the same as the steerable catheter assembly as described in FIG. 5. The robotic bronchoscope may be a single-use robotic endoscope. In some cases, only the catheter may be disposable. In some cases, at least a portion of the catheter may be disposable. In some cases, the entire robotic bronchoscope may be released from the instrument driving mechanism and may be disposed of. In some cases, the bronchoscope may contain varying levels of stiffness along its shaft, as to improve functional operation. In some cases, a minimum bend radius along the shaft may vary.Atomey Docket No. 55441-730601
[0170] The robotic bronchoscope may be releasably coupled to an instrument driving mechanism 620. The instrument driving mechanism 620 may be mounted to the arm of the robotic support system or to any actuated support system as described elsewhere herein. The instrument driving mechanism may provide mechanical and electrical interface to the robotic bronchoscope 610. The mechanical interface may allow the robotic bronchoscope 610 to be releasably coupled to the instrument driving mechanism. For instance, the handle portion of the robotic bronchoscope may be attached to the instrument driving mechanism via quick install / release means, such as magnets and spring-loaded levels. In some cases, the robotic bronchoscope may be coupled or released from the instrument driving mechanism manually without using a tool (e.g., such as a medical tool).
[0171] FIG. 7 shows an example of an instrument driving mechanism (TDM) 720 providing mechanical interface to the handle portion 713 of the robotic bronchoscope. As shown in the example, the instrument driving mechanism 720 may comprise a set of motors that are actuated to rotationally drive a set of pull wires of the flexible endoscope or catheter. The handle portion 713 of the catheter assembly may be mounted onto the instrument drive mechanism so that its pulley assemblies or capstans are driven by the set of motors. The number of pulleys may vary based on the pull wire configurations. In some cases, one, two, three, four, or more pull wires may be utilized for articulating the flexible endoscope or catheter.
[0172] The handle portion may be configured allowing the robotic bronchoscope to be disposable at reduced cost. For instance, classic manual and robotic bronchoscopes may have a cable in the proximal end of the bronchoscope handle. The cable often comprises illumination fibers, camera video cable, and other sensors fibers or cables such as electromagnetic (EM) sensors, or shape sensing fibers. Such complex cable may be expensive, adding to the cost of the bronchoscope. The provided robotic bronchoscope may have an optimized design such that simplified structures and components may be employed while preserving the mechanical and electrical functionalities. In some cases, the handle portion of the robotic bronchoscope may employ a cable-free design while providing a mechanical / electrical interface to the catheter.
[0173] FIG. 8 shows another example of a disposable endoscope 800 removably coupled to an IDM 801. The one or more endoscope components located at the handle 809 may be optimized such that expensive and complicated components may be allocated to the robotic support system 803, a hand-held controller or an instrument driving mechanism 801 thereby reducing the cost and simplifying the design the disposable endoscope. The handle portion or proximal portion 809 may provide an electrical interface 805 and mechanical interface to allow for electrical communication and mechanical communication with the instrument drivingAtomey Docket No. 55441-730601 mechanism 801. The instrument driving mechanism 801 may comprise a set of motors that are actuated to rotationally drive a set of pull wires of the catheter. The handle portion 809 of the catheter assembly may be mounted onto the instrument drive mechanism 801 so that its pulley / capstans assemblies are driven by the set of motors. For example, the handle pulley may interact with an output shaft 803 from the IDM supported by the robotic system The number of pulleys may vary based on the pull wire configurations. In some cases, one, two, three, four, or more pull wires may be utilized for articulating the flexible endoscope or catheter.
[0174] FIG. 9 shows an example of a distal tip 900 of an endoscope. In some cases, the distal portion or tip of the catheter 900 may be substantially flexible such that it may be steered into one or more directions (e.g., pitch, yaw). The catheter may comprise a tip portion 901, bending section, and insertion shaft. In some embodiments, the catheter may have variable bending stiffness along the longitudinal axis direction. For instance, the catheter may comprise multiple sections having different bending stiffness (e.g., flexible, semi-rigid, and rigid). The bending stiffness may be varied by selecting materials with different stiffness / rigidity, varying structures in different segments (e.g., cuts, patterns), adding additional supporting components or any combination of the above. In some embodiments, the catheter may have variable minimum bend radius along the longitudinal axis direction. The selection of different minimum bend radius at different location long the catheter may beneficially provide anti-prolapse capability while still allow the catheter to reach hard-to-reach regions. In some cases, a proximal end of the catheter needs not be bent to a high degree thus the proximal portion of the catheter may be reinforced with additional mechanical structure (e.g., additional layers of materials) to achieve a greater bending stiffness. Such design may provide support and stability to the catheter. In some cases, the variable bending stiffness may be achieved by using different materials during extrusion of the catheter. This may advantageously allow for different stiffness levels along the shaft of the catheter in an extrusion manufacturing process without additional fastening or assembling of different materials.
[0175] The distal portion of the catheter may be steered by one or more pull wires 905. The distal portion of the catheter may be made of any suitable material such as co-polymers, polymers, metals, or alloys such that it may be bent by the pull wires. In some embodiments, the proximal end or terminal end of one or more pull wires 905 may be coupled to a driving mechanism (e.g., gears, pulleys, capstan etc.) via the anchoring mechanism as described above.
[0176] The pull wire 905 may be a metallic wire, cable, or thread, or it may be a polymeric wire, cable, or thread. The pull wire 905 may also be made of natural or organic materials or fibers. The pull wire 905 may be any type of suitable wire, cable, or thread capableAtomey Docket No. 55441-730601 of supporting various kinds of loads without deformation, significant deformation, or breakage. The distal end or portion of one or more pull wires 905 may be anchored or integrated to the distal portion of the catheter, such that operation of the pull wires by the control unit may apply force or tension to the distal portion which may steer or articulate (e.g., up, down, pitch, yaw, or any direction in-between) at least the distal portion (e.g., flexible section) of the catheter.
[0177] The catheter may have a dimension so that one or more electronic components may be integrated to the catheter. For example, the outer diameter of the distal tip may be around 4 to 4.4 millimeters (mm), and the diameter of the working channel 903 may be around 2 mm such that one or more electronic components may be embedded into the wall of the catheter. However, it should be noted that based on different applications, the outer diameter may be in any range smaller than 4 mm or greater than 4.4 mm, and the diameter of the working channel may be in any range according to the tool dimensional or specific application.
[0178] The one or more electronic components may comprise an imaging device, illumination device or sensors. In some embodiments, the imaging device may be a video camera 913. The imaging device may comprise optical elements and image sensor for capturing image data. The image sensors may be configured to generate image data in response to wavelengths of light. A variety of image sensors may be employed for capturing image data such as complementary metal oxide semiconductor (CMOS) or charge-coupled device (CCD). The imaging device may be a low-cost camera. In some cases, the image sensor may be provided on a circuit board. The circuit board may be an imaging printed circuit board (PCB). The PCB may comprise a plurality of electronic elements for processing the image signal. For instance, the circuit for a CCD sensor may comprise A / D converters and amplifiers to amplify and convert the analog signal provided by the CCD sensor. Optionally, the image sensor may be integrated with amplifiers and converters to convert analog signal to digital signal such that a circuit board may not be required. In some cases, the output of the image sensor or the circuit board may be image data (digital signals) may be further processed by a camera circuit or processors of the camera. In some cases, the image sensor may comprise an array of optical sensors.
[0179] The illumination device may comprise one or more light sources 911 positioned at the distal tip. The light source may be a light-emitting diode (LED), an organic LED (OLED), a quantum dot, or any other suitable light source. In some cases, the light source may be miniaturized LED for a compact design or Dual Tone Flash LED Lighting.
[0180] The imaging device and the illumination device may be integrated to the catheter. For example, the distal portion of the catheter may comprise suitable structures matching at leastAtomey Docket No. 55441-730601 a dimension of the imaging device and the illumination device. The imaging device and the illumination device may be embedded into the catheter. FIG. 10 shows an example distal portion of the catheter with integrated imaging device and the illumination device. A camera may be located at the distal portion. The distal tip may have a structure to receive the camera, illumination device and / or the location sensor. For example, the camera may be embedded into a cavity 1010 at the distal tip of the catheter. The cavity 1010 may be integrally formed with the distal portion of the cavity and may have a dimension matching a length / width of the camera such that the camera may not move relative to the catheter. The camera may be adjacent to the working channel 1020 of the catheter to provide near field view of the tissue or the organs. In some cases, the attitude or orientation of the imaging device may be controlled by controlling a rotational movement (e.g., roll) of the catheter.
[0181] The power to the camera may be provided by a wired cable. In some cases, the cable wire may be in a wire bundle providing power to the camera as well as illumination elements or other circuitry at the distal tip of the catheter. The camera and / or light source may be supplied with power from a power source located at the handle portion via wires, copper wires, or via any other suitable means running through the length of the catheter. In some cases, realtime images or video of the tissue or organ may be transmitted to an external user interface or display wirelessly. The wireless communication may be Wi-Fi, Bluetooth, RF communication or other forms of communication. In some cases, images or videos captured by the camera may be broadcasted to a plurality of devices or systems. In some cases, image and / or video data from the camera may be transmitted down the length of the catheter to the processors situated in the handle portion via wires, copper wires, or via any other suitable means. The image or video data may be transmitted via the wireless communication component in the handle portion to an external device / system. In some cases, the endoscope system may be configured such that no wires are visible or exposed to operators.
[0182] In conventional endoscopy, illumination light may be provided by fiber cables that transfer the light of a light source located at the proximal end of the endoscope, to the distal end of the robotic endoscope. In some embodiments of the disclosure, miniaturized LED lights may be employed and embedded into the distal portion of the catheter to reduce the design complexity. In some cases, the distal portion may comprise a structure 1030 having a dimension matching a dimension of the miniaturized LED light source. As shown in the illustrated example, two cavities 1030 may be integrally formed with the catheter to receive two LED light sources. For instance, the outer diameter of the distal tip may be around 4 to 4.4 millimeters (mm) and diameter of the working channel of the catheter may be around 2 mm such that two LED lightAtomey Docket No. 55441-730601 sources may be embedded at the distal end. The outer diameter may be in any range smaller than 4 mm or greater than 4.4 mm, and the diameter of the working channel may be in any range according to the tool's dimensional or specific application. Any number of light sources may be comprised. The internal structure of the distal portion may be configured to fit any number of light sources.
[0183] In some cases, each of the LEDs may be connected to power wires which may run to the proximal handle. In some embodiment, the LEDs may be soldered to separated power wires that later bundle together to form a single strand. In some embodiments, the LEDs may be soldered to pull wires that supply power. In other embodiments, the LEDs may be crimped or connected directly to a single pair of power wires. In some cases, a protection layer such as a thin layer of biocompatible glue may be applied to the front surface of the LEDs to provide protection while allowing light emitted out. In some cases, an additional cover 1031 may be placed at the forwarding end face of the distal tip providing precise positioning of the LEDs as well as sufficient room for the glue. The cover 1031 may be composed of transparent material matching the refractive index of the glue so that the illumination light may not be obstructed.
[0184] It should be noted that the illustrated distal end design is for illustration purpose only. There may be other suitable design for integrating the one or more endoscope components into the distal tip. FIG. 11 shows another example of a distal portion 1100 of the catheter with integrated imaging device and the illumination device. As shown in the example 1100, the distal tip may have a structure 1101 to receive the camera, a structure 1103 to receive an illumination device and / or the location sensor. The camera may be embedded into a cavity 1101 at the distal tip of the catheter. The cavity 1101 may be integrally formed with the distal portion of the cavity and may have a dimension matching a length / width of the camera such that the camera may not move relative to the catheter. The camera may be adjacent to the working channel 1107 of the catheter to provide near field view of the tissue or the organs. In some cases, the attitude or orientation of the imaging device may be controlled by controlling a rotational movement (e.g., roll) of the catheter. As shown in the illustrated example 1100, a cavity 1103 may be integrally formed with the catheter to receive an LED light source.
[0185] As used herein a processor encompasses one or more processors, for example a single processor, or a plurality of processors of a distributed processing system for example. A controller or processor as described herein generally comprises a tangible medium to store instructions to implement steps of a process, and the processor may comprise one or more of a central processing unit, programmable array logic, gate array logic, or a field programmable gate array, for example. In some cases, the one or more processors may be a programmableAtomey Docket No. 55441-730601 processor (e.g., a central processing unit (CPU) or a microcontroller), digital signal processors (DSPs), a field programmable gate array (FPGA) and / or one or more Advanced RISC Machine (ARM) processors. In some cases, the one or more processors may be operatively coupled to a non-transitory computer readable medium. The non-transitory computer readable medium may store logic, code, and / or program instructions executable by the one or more processors unit for performing one or more steps. The non-transitory computer readable medium may comprise one or more memory units (e.g., removable media or external storage such as an SD card or random access memory (RAM)). One or more methods or operations disclosed herein may be implemented in hardware components or combinations of hardware and software such as, for example, ASICs, special purpose computers, or general purpose computers.
[0186] The one or more processors may be in communication with the endoscope. The one or more processors may be located remotely from the endoscope system or onboard of the endoscope system (e.g., located at the handle, located at the user device for controlling the endoscope).
[0187] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.
Claims
Atorney Docket No. 55441-730601CLAIMSWHAT IS CLAIMED IS:
1. A method for stabilizing an articulatable flexible endoscope, the method comprising:(a) navigating the articulatable flexible endoscope towards a target site, wherein the articulatable flexible endoscope comprises a bending section steerable by a plurality of pull wires;(b) computing a compression pull-force or a compression pull-length for each of the plurality of pull wires based at least in part on i) a target increase in a flexural rigidity of the bending section and ii) a current bend angle of a distal tip portion of the articulatable flexible endoscope; and(c) executing a control algorithm to increase a force applied to the plurality of pull wires until the compression pull-force computed in (b) is reached or the compression pull-length for each pull wire computed in (b) is reached, thereby stabilizing the distal tip portion or the bending section of the articulatable flexible endoscope.
2. The method of claim 1, wherein the target increase in the flexural rigidity of the bending section is predetermined.
3. The method of claim 2, wherein the target increase in the flexural rigidity of the bending section is predetermined based at least in part on an undesired deflection of the distal tip portion caused by inserting an instrument into a working channel of the articulatable flexible endoscope.
4. The method of claim 1, wherein the compression pull-force or the compression pulllength for each of the plurality of pull wires is further computed based on a calibration information.
5. The method of claim 4, wherein the calibration information comprises a set of compensation tensions or compensation lengths for the plurality of pull wires at various bend angles.
6. The method of claim 1, wherein the control algorithm comprises generating a command to an instrument driving mechanism (IDM) configured to actuate the plurality of pull wires.
7. The method of claim 6, wherein the command comprises an instruction to the instrument driving mechanism (IDM) to pull the plurality of pull wires simultaneously using a ramp trajectory.
8. The method of claim 1, further comprising disabling an articulation function of the articulatable flexible endoscope prior to executing the control algorithm in (c).Atomey Docket No. 55441-7306019. The method of claim 8, further comprising re-enabling the articulation function of the articulatable flexible endoscope after completion of executing the control algorithm in (c).
10. The method of claim 9, wherein re-enabling the articulation function comprises releasing the compression pull-force or the compression pull-length for the plurality of pull wires.
11. A system for stabilizing an articulatable flexible endoscope, the system comprising: one or more processors configured to execute instructions to perform operations comprising:(a) navigating the articulatable flexible endoscope towards a target site, wherein the articulatable flexible endoscope comprises a bending section steerable by a plurality of pull wires;(b) computing a compression pull-force or a compression pull-length for each of the plurality of pull wires based at least in part on i) a target increase in a flexural rigidity of the bending section and ii) a current bend angle of a distal tip portion of the articulatable flexible endoscope; and(c) executing a control algorithm to increase a force applied to the plurality of pull wires until the compression pull-force computed in (b) is reached or the compression pull-length for each pull wire computed in (b) is reached, thereby stabilizing the distal tip portion or the bending section of the articulatable flexible endoscope.
12. The system of claim 11, wherein the target increase in the flexural rigidity of the bending section is predetermined.
13. The system of claim 12, wherein the target increase in the flexural rigidity of the bending section is predetermined based at least in part on an undesired deflection of the distal tip portion caused by inserting an instrument into a working channel of the articulatable flexible endoscope.
14. The system of claim 11, wherein the compression pull-force or the compression pulllength for each of the plurality of pull wires is further computed based on a calibration information.
15. The system of claim 14, wherein the calibration information comprises a set of compensation tensions or compensation lengths for the plurality of pull wires at various bend angles.
16. The system of claim 11, wherein the control algorithm comprises generating a command to an instrument driving mechanism (IDM) configured to actuate the plurality of pull wires.Atomey Docket No. 55441-73060117. The system of claim 16, wherein the command comprises an instruction to the instrument driving mechanism (IDM) to pull the plurality of pull wires simultaneously using a ramp trajectory.
18. The system of claim 11, wherein the operations further comprise disabling an articulation function of the articulatable flexible endoscope prior to executing the control algorithm in (c).
19. The system of claim 18, wherein the operations further comprise re-enabling the articulation function of the articulatable flexible endoscope after completion of executing the control algorithm in (c).
20. The system of claim 19, wherein re-enabling the articulation function comprises releasing the compression pull-force or the compression pull-length for the plurality of pull wires.
21. A system for stabilizing an articulatable flexible endoscope, the system comprising: a navigation unit configured to guide the articulatable flexible endoscope towards a target site, wherein the articulatable flexible endoscope comprises a bending section steerable by a plurality of pull wires; a processing unit configured to compute a compression pull-force or a compression pulllength for each of the plurality of pull wires based at least in part on i) a target increase in a flexural rigidity of the bending section and ii) a current bend angle of a distal tip portion of the articulatable flexible endoscope; and a control unit configured to execute a control algorithm to increase a force applied to the plurality of pull wires until the compression pull-force is reached or the compression pull-length for each pull wire is reached, thereby stabilizing the distal tip portion or the bending section of the articulatable flexible endoscope.
22. The system of claim 21, wherein the processing unit is configured to compute the target increase in the flexural rigidity of the bending section as predetermined.
23. The system of claim 22, wherein the processing unit is configured to compute the target increase in the flexural rigidity of the bending section as predetermined based at least in part on an undesired deflection of the distal tip portion caused by inserting an instrument into a working channel of the articulatable flexible endoscope.
24. The system of claim 21, wherein the processing unit is further configured to compute the compression pull-force or the compression pull-length for the plurality of pull wires based on calibration information.Atomey Docket No. 55441-73060125. The system of claim 24, wherein the calibration information comprises a set of compensation tensions or compensation lengths for the plurality of pull wires at various bend angles.
26. The system of claim 21, wherein the control unit is configured to generate a command to an instrument driving mechanism (IDM) configured to actuate the plurality of pull wires.
27. The system of claim 26, wherein the command comprises an instruction to the instrument driving mechanism (IDM) to pull the plurality of pull wires simultaneously using a ramp trajectory.
28. The system of claim 21, wherein the processing unit is further configured to disable an articulation function of the articulatable flexible endoscope prior to executing the control algorithm.
29. The system of claim 28, wherein the processing unit is further configured to re-enable the articulation function of the articulatable flexible endoscope after executing the control algorithm.
30. The system of claim 29, wherein re-enabling the articulation function comprises releasing the compression pull-force or the compression pull-length for the plurality of pull wires.
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